Evolut Medtronic has been awarded CE mark for the use of the Evolut transcatheter aortic valve implantation (TAVI) system for patients with severe native aortic stenosis who are at low surgical risk. The Evolut TAVI platform has also received a new indication approval for the treatment of patients with bicuspid aortic valves [...]
Picso system Miracor Medical has announced the award of the CE mark for its latest generation of PiCSO Impulse Catheter and PiCSO Impulse Console, which is indicated for the treatment of anterior STEMI patients. It says the new system features improvements in ease of use. PiCSO therapy is delivered during primary percutaneous [...]
Foldax has announced the closing of a $20 million Series D round of funding. According to a press release, MemorialCare Innovation Fund (MCIF) led the round, with Angel Physicians Fund (APF) and Sayan Bioventures joining as new investors. All existing investors also participated in the round, including BioStar Capital, Kairos Ventures and Caltech. Brant [...]
A press release reports that Rexgenero has acquired all the key technology and program assets of aratinga.bio SAS Group. It adds that the acquisition, which follows the recent approval by the French Commercial Court, includes all patent applications and related intellectual property, the exclusive license agreement for polymeric nanoparticle technology and the bioproduction facilities [...]
Members of CAMP PCI’s faculty take questions from physician participants during the first virtual training on 5 June 2020, broadcast live from Abiomed’s Heart Recovery Institute Abiomed has launched a virtual physician education programme, CAMP PCI (Coronary artery and myocardial protected percutaneous coronary intervention), to improve high-risk PCI patient outcomes. A press [...]
Endologix has announced that Vaseem Mahboob, chief financial officer (CFO), will be departing the company effective 1 July 2020 to become CFO of a private global healthcare company. Cindy Pinto, vice president, Financial Planning & Analysis, will assume the role of interim CFO in addition to her current responsibilities, and Endologix has initiated a [...]
A study, by Offer Amir (Heart Institute, Hadassah Medical Centre, Jerusalem, Israel) and colleagues, indicates that voice analysis by a smartphone app could be used to identify lung congestion in heart failure patients, allowing early intervention before their condition deteriorates. The small study was presented HFA Discoveries, a scientific platform of the European Society [...]
Cobalt ICD Medtronic has received FDA approval for its Cobalt and Crome implantable cardioverter-defibrillators (ICD) and cardiac resynchronisation therapy-defibrillators (CRT-D). ICDs monitor heart rhythms and deliver therapy to correct heart rates that are too fast and can lead to sudden cardiac arrest. CRT-Ds, a treatment option for some individuals with heart failure, [...]
Cook Medical and Surmodics have announced an agreement in which Cook Medical will distribute two new Surmodics products, hydrophilic percutaneous transluminal angioplasty (PTA) balloon catheters that can be used over 0.014-inch and a 0.018-inch wire guides. “We have had a long relationship with Surmodics, utilising its innovative surface modification technology with many of our [...]
Treo stent graft Terumo Aortic has announced that the FDA has granted approval of the Treo abdominal aortic stent-graft system for sale in the USA for the treatment of patients with abdominal aortic aneurysms (AAA). According to a press release, Treo is the only device commercially available for endovascular aneurysm repair (EVAR) with dual [...]
Aspire MAX mechanical thrombectomy system Control Medical Technology has announced that the US Food and Drug Administration (FDA) has cleared its Aspire MAX 7 – 11F mechanical thrombectomy platform to remove blood clots from peripheral vessels. “This FDA clearance quadruples our product offering and improves our ability to help patients,” said Shawn Fojtik, president [...]
Necklace-ECG A necklace that detects abnormal heart rhythm will be showcased for the first time on EHRA Essentials 4 You, a scientific platform of the European Society of Cardiology (ESC). According to the study’s author, Elmeri Santala from the University of Eastern Finland, the wearable necklace-ECG (electrocardiogram) provides “a new and easy method for detecting [...]
LifeSignal remote monitoring patch LifeSignals has received CE mark approval for the LifeSignals ECG Remote Monitoring Patch, a disposable wireless remote monitoring system, intended for use by healthcare professionals for continuous collection of Electrocardiography (ECG) and heart rate monitoring in ambulatory, hospital, healthcare and home settings. Patient data can be transmitted wirelessly [...]
TherOX DS2 ZOLL Medical has received CE Mark approval to market and distribute its SuperSaturated oxygen (SSO2) therapy system in Europe. A press release reports that SSO2 therapy provides interventional cardiologists with the first and only clinically proven treatment beyond percutaneous coronary intervention (PCI) to significantly reduce muscle damage in myocardial infarction [...]
Source: BIBA MedTech Insights At the American College of Cardiology/World Congress of Cardiology’s virtual scientific sessions (ACC.20/WCC Virtual; 28–30 March, Chicago, USA), D Scott Lim (University of Virginia, Charlottesville, USA) reported that mitral regurgitation ≤1+ was achieved more frequently with MitraClipNTR or with MitraClipXTR (both Abbott) than previously observed with the first-generation [...]
A BIBA MedTech Insights survey indicates that 50% of centres performing structural heart procedures believe that they will need to increase the number of operating days per week to manage the elective cases that have been put on hold because of COVID-19. However, 22% believe that no extra measures will be required and the backlog will [...]
Abiomed (maker of the Impella heart pump) has acquired Breethe, developer of a novel extracorporeal membrane oxygenation (ECMO) system. A press release reports that the acquisition will complement and expand Abiomed’s product portfolio to more comprehensively serve the needs of patients whose lungs can no longer provide sufficient oxygenation. Such patients include those with cardiogenic [...]
Nathaniel Hagedorn Artio Medical has announced the appointment of entrepreneur and businessman Nathaniel Hagedorn to its board of directors. As the founder and CEO of NorthPoint Development, Hagedorn has raised over $6.5B in capital and brings nearly two decades of experience in accessing new markets and scaling new business opportunities. Hagedorn founded [...]
Thoraflex Hybrid stented device Terumo Aortic today announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for its Thoraflex Hybrid stented device for complex aortic arch repair. The purpose of the FDA’s breakthrough device designation programme is to fast-track the regulatory review process for certain medical technologies and device-led [...]
EOSedge Alphatec Holdings (ATEC) has terminated the tender offer agreement (TOA), dated 26 February 2020, under which it was to acquire EOS imaging for up to US$88 million in a combination of cash and equity. EOS imaging is a specialist in orthopaedic medical imaging and software solutions. The EOS technology informs the [...]
Cerus Endovascular has received CE mark approval for its 0.021-inch Contour neurovascular system, compatible with smaller commercially available 021 microcatheters for the treatment of saccular intracranial aneurysms. According to the company, the Contour neurovascular system is a fine mesh braid that is deployed across the neck of the aneurysm sac and provides a combination [...]
Terumo Europe today announced that their BioPearl microspheres have received CE mark, providing a new option for patients eligible for locoregional embolization for the treatment of liver cancer. BioPearl microspheres are designed to preserve post-transarterial chemoembolization (TACE) target artery access, opening up the potential for cyclic treatment. Currently, drug-eluting microsphere TACE (DEM-TACE) and conventional TACE are both [...]
VisCardia, Inc. VisCardia has been granted Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its implantable VisONE system, which is designed for the treatment of moderate-to-severe heart failure with reduced ejection fraction and preserved ventricular synchrony. A press release reports that VisONE has now completed the first phase of the [...]
Acurate neo (first generation) Boston Scientific, according to a press release announcing the company’s Q1 2020 financial results, has received the CE mark for its Acurate neo2 aortic valve system. The press release reports that the transcatheter aortic valve implantation (TAVI) system builds on the clinical performance of the original Acurate neo [...]
Robocath, which designs, develops and commercialises cardiovascular robotic systems for the treatment of vascular diseases, has secured €40 million ($43M) in a series C round of financing. A press release reports that this was led by MicroPort Scientific Corporation, with participation from institutional investors (Zhejiang Silk Road Fund, Luxembourg CLIIF managed under TUS-Holdings, CS [...]
On 18 March, the Centers for Medicare & Medicaid Services (CMS) recommended “limiting non-essential care and expanding surge capacity into ambulatory surgical centres and other areas” to conserve resources and staff for managing COVID-19 patients. However, in a statement issued on 19 April, it now said it recognises “at this time, many areas [in [...]
Leaflex Pi-Cardia has closed a US$27 million round of financing, led by Sofinnova Partners. A press release reports that Pi-Cardia’s Leaflex catheter performs mechanical scoring of valve calcification, restoring leaflets’ mobility and improving valve haemodynamics. The Leaflex catheter is designed to be a cost-effective, durable standalone treatment. It can be used for [...]
Elucid Bioimaging Proximo Medical has announced a partnership with Elucid Bioimaging, a developer of diagnostic image analysis software used to assist in the detection and treatment of myocardial infarction and stroke. A press release states that Elucid Bioimaging’s signature technology, vascuCAP, is the only Food and Drug Administration (FDA)-cleared, histologically-validated software for [...]
Jon George Studies have shown that robotic percutaneous coronary intervention (PCI) with the CorPath GRX System (Corindus, now part of Siemens Healthineers)—compared with manual PCI—reduces radiation exposure to the cath lab staff and may also improve precision. Furthermore, during the current pandemic, it potentially could help to reduce contact with COVID-19 patients [...]
Boston Scientific has announced that its annual meeting of stockholders will be held exclusively in a virtual meeting format on 7 May 8am Eastern Time. The virtual meeting, which will be conducted via live audio webcast, is in response to the public health impact of the COVID-19, in accordance with orders issued by the [...]
Zimmer Biomet has announced that, because of the effect of the pandemic, it estimates revenue growth for the first quarter 2020 will be approximately -9.5 to -10.5% on a reported basis and -8.5 to -9.5% on a constant currency basis when compared to the first quarter of 2019. Additionally, the company is taking several [...]
In image A, the breast tissue has been stained with Her2-UCNP reagent, in order to visualize cells containing Her2, which is a common marker in breast cancer diagnostic. Image B shows staining in the same tissue sample as in image A, but performed with the standard DAB-based method. Images A and B show [...]
i:X MolecuLight has announced the integration of its MolecuLight i:X device with Tissue Analytics’ interconnected platform for seamless integration with leading electronic medical record (EMR)/electronic health record (EHR) platforms. According to a press release, Tissue Analytics is an artificial intelligence (AI)-powered cloud-based software solution that allows providers to monitor and automatically measure [...]
Tim Attebery has resigned as CEO of the American College of Cardiology (ACC) and MedAxiom, as the result of changing personal and family priorities. The ACC Board of Trustees has selected Cathleen Gates as interim CEO for the near future. Attebery joined the College as CEO in September 2018. During his tenure, the College [...]
Tack Endovascular System (4F) Intact Vascular has received FDA approval for the Tack Endovascular System (4F), a novel, minimal metal implant for precision dissection repair in the mid/distal popliteal, tibial and/or peroneal arteries. Regulatory approval was based on data from Intact Vascular’s Tack Optimised Balloon Angioplasty II BTK (TOBA II BTK) clinical [...]
Axonics has announced the FDA approval of its next-generation rechargeable implantable neurostimulator for its r-SNM system under a premarket approval (PMA) supplement. This next-generation implantable neurostimulator decreases how frequently a patient needs to recharge their implanted device to once a month for about one hour. This compares to the current recharging interval which is [...]
Stryker’s Emergency Relief Bed, a limited-release medical bed, supports critical needs during COVID-19 pandemic. Stryker has announced the development of a limited-release emergency response bed to quickly aid healthcare providers with efficient care during the COVID-19 pandemic. The Emergency Relief Bed is a low-cost solution intended to serve frontline healthcare providers. It includes a [...]
Michael Kiernan Physicians recognised the importance of remote management for heart failure patients long before the COVID-19 pandemic. However, the current situation has heightened the urgency of the transition for this vulnerable population. In this commentary, Michael Kiernan reviews how remote monitoring of heart failure patients could help to reduce heart failure [...]
Selution SLR MedAlliance has announced enrolment of the first patient in the SAVE (Use of the Selution sirolimus-eluting balloon for dysfunctional AV access treatment indications) study utilising their novel sirolimus-eluting balloon, for the treatment of failed arteriovenous (AV) fistulae in renal dialysis patients. The objectives of this prospective, randomised, single-blind multicentre study [...]
The US Food and Drug Administration (FDA) issued an emergency use authorisation for a blood purification system (Spectra Optia Apheresis System, Terumo BCT) combined with Adsorption Cartridge (Marker Therapeutics) to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure. A [...]
Santiago Garcia Santiago Garcia (Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, USA) and colleagues report in the Journal of American College of Cardiology that there was a 38% drop in cath lab ST-segment elevation myocardial infarction (STEMI) activations in the USA after the COVID-19 pandemic started to substantially affect US social life and [...]
TriClip Abbott has received the CE mark for its TriClip transcatheter tricuspid valve repair system and is now approved for use in Europe and other countries that recognise the CE mark. It can, therefore, be used as a non-surgical treatment for people with a leaky tricuspid valve. A press release reports that [...]
Shockwave Medical has completed enrolment in its US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study—DISRUPT CAD III—for the use of intravascular lithotripsy (IVL) for the management of heavily calcified coronary arteries. A press release reports that the investigational Shockwave IVL system with the Shockwave C2 Coronary IVL catheter, which has been [...]
Symplicity Spyral Data published in the Lancet—and simultaneously presented at the American College of Cardiology together with World Congress of Cardiology Scientific Sessions (ACC.20/WCC) virtual meeting (28–30 March, Central Time)—provide further evidence that renal denervation with the Symplicity Spyral (Medtronic) catheter is an effective approach for lowering blood pressure in patients who [...]
Edwards Lifesciences has temporarily paused new enrolments in its active pivotal clinical trials of its transcatheter mitral and tricuspid therapies in response to ongoing COVID-19 pandemic. A press release reports that the company is coordinating closely with the trials’ clinical investigators at the relevant hospital. It adds that the decision to resume enrolments in [...]
The European Commission (EC) has adopted a proposal to postpone by one year the date of application of the new Medical Devices Regulation (MDR), which was due to come into force on 26 May this year. The postponement, a press release reports, is to allow Member States, health institutions and economic operators to prioritise [...]
BD and BioMedomics have announced the release of a new point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes. A press release states that the new test, developed and manufactured by BioMedomics, will be available through BD—and distributed exclusively by Henry [...]
OrthoPediatrics has acquired ApiFix, including its minimally invasive deformity correction (MID-C) system for non-fusion treatment of progressive adolescent idiopathic scoliosis, for 934,768 shares of OrthoPediatrics common stock and US$2 million in cash paid at closing, plus milestone payments and an earnout over a period of four years. A press release reports that ApiFix is [...]
Mardil Medical has announced the successful completion of treatment for the third patient in the clinical trial of its improved VenTouch device for type IIIb functional mitral valve regurgitation. A press release reports that the device is a combination therapy which simultaneously treats the distorted valve, the dilated ventricle and the displaced papillary muscles. [...]
In a new statement published on 2 April 2020, all 45 societies represented by the US Council of Medical Specialty Societies (CMSS)—over 800,000 physicians—emphatically declare their belief that all frontline healthcare professionals must have access to personal protective equipment (PPE) and be able to speak publicly about the lack of PPE without retribution while pushing for [...]
COVID-19 Abbott has announced that the FDA has issued Emergency Use Authorisation (EUA) for the its molecular test for COVID-19. According to a press release, Abbott is immediately shipping 150,000 Abbott RealTime SARS-CoV-2 EUA tests to existing customers in the USA. The tests are used on the company’s m2000 RealTime System. The [...]
Medtronic is publicly sharing the design specifications for the Puritan Bennett 560 (PB 560) to enable participants across industries to evaluate options for rapid ventilator manufacturing to help efforts to manage patients with COVID-19. A press release reports that this this decision is consistent with the recent FDA Guidance and in accordance with the [...]
Boston Scientific has revealed that its assuming the Q2 2020 impact of COVID-19 will be more significant than that of Q1 2020. As a result, the company is “taking proactive steps to reduce costs and be in a strong position to support customers and patients when healthcare systems begin to recover, and elective procedures [...]
Helen Xun In response to a pressing need for more ventilators to treat critically ill COVID-19 patients, Sung Hoon Kang (Johns Hopkins Whiting School of Engineering, Baltimore, USA) and colleagues are developing and prototyping a 3D-printed splitter that will allow a single ventilator to treat multiple patients. The team has designed this [...]
Stroke is the second leading cause of mortality and the third leading cause of adult disability in the USA, causing severe long-term impairments in the lives of survivors. While the two kinds of stroke—ischaemic (85%) and haemorrhagic (15%)—differ in their origins, both culminate in compromised blood supply and subsequent brain ischaemia. This results in [...]
Late-breaking data presented at the American College of Cardiology together with World Congress of Cardiology Scientific Sessions (ACC.20/WCC) virtual meeting (28–30 March, Central Time) show that transcatheter aortic valve implantation (TAVI) with the Evolut device (Medtronic) in low-risk patients with bicuspid aortic valves is associated with low rates of all-cause mortality or stroke at [...]
TherOX DS2 Zoll has received FDA approval of the second-generation TherOx system, which—a press release reports—provides super-saturated oxygen (SSO2) therapy. SSO2 therapy is designed to deliver hyperbaric levels of oxygen directly to the damaged heart muscle immediately after successful revascularisation via angioplasty and stenting of the blocked coronary artery. The press release [...]
MolecuLight is to sponsor and participate in the virtual exhibit of WoundCon Spring 2020—a one-day conference and exhibition to be held on 2 April 2020. According to a press release, WoundCon has become the largest conference for wound care, with more than 10,000 wound care professionals registered for the one-day clinical conference and virtual exhibition. [...]
FibriCheck, a CE-mark and FDA-approved medical app, has launched the first smartwatch app that automatically monitors users’ heart rhythms during their sleep. The app, which can be integrated into any brand of smartwatch, detects episodes of both intermittent and silent atrial fibrillation. A press release reports that FibriCheck’s latest innovation offers an easy and [...]
A new website—www.doctorinthehouse.net—is calling for healthcare professionals to volunteer for its free virtual consultation service. The aim of the service, according to a press release, is to ease the pressure on the NHS during the COVID-19 outbreak by giving patients first-hand, remote, consultations while the UK is on lockdown. The press release states that [...]
Artio Medical, a medical device company developing innovative products for the peripheral vascular and neurovascular markets, has closed an additional $8.8 million in Series A financing, bringing the total capital raised to date to more than $20 million. The additional funds will help Artio obtain 510(k) marketing clearance from the FDA to market the [...]
The 2020 Charing Cross (CX) Symposium that was due to take place next month in London, UK, has been cancelled due to COVID-19. In full, the statement from the CX Symposium team, reads: “The CX Symposium team has made the difficult but necessary decision to cancel the Charing Cross Symposium 2020 that was scheduled to take [...]
The UK National Institute for Health and Care Excellence (NICE) has published guidelines on abdominal aortic aneurysm (AAA) diagnosis and management. Discussion between physicians and patients to consider the risks of any intervention versus no intervention is encouraged, and, while the guidelines are in favour of open repair for most patients, they also highlight [...]
Aram Saeed (School of Pharmacy, University of East Anglia [UAE], Norwich, UK) and others have launched a project to 3D print ventilator parts, masks and other critical equipment to manage the COVID-19 virus. According to a press release, they are working with the tech community to access 3D printers, as well people with the [...]
Mary M McDermott A viewpoint in the Journal of the American Medical Association (JAMA) has offered potential solutions to modifying ongoing randomised clinical trials during the COVID-19 pandemic. It aims to “minimise disruption and preserve integrity”, while still ensuring participant health and safety. Authors Mary M McDermott (deputy editor of JAMA, and [...]
As a response to the ongoing global COVID-19 pandemic, PRA Health Sciences has announced the expansion of its Mobile Health Platform for remote clinical monitoring, adding several new capabilities that address sponsor needs for COVID-19 virtual study support. A press release states that the Mobile Health Platform (MHP) engages with patients wherever they are. [...]
Kardia 6L AliveCor’s KardiaMobile 6L—the world’s only six lead personal ECG—is now allowed for use in the measurement of a patient’s QTc and detection of potentially dangerous QT prolongation. A prolonged QTc can lead to a potentially fatal side effect, which is associated with the use of several medicines now being used [...]
During a Q&A section of a European Commission (EC) college meeting on 25 March, EC spokesperson Stefan de Keersmaecker stated that the commission were looking to delay the “entry into force” of the new European medical device regulations (MDR) because of the global coronavirus pandemic. de Keersmaecker, who spoke via video, said: “The EC [...]
Ron Solar Ron Solar (ThermopeutiX, San Diego, USA) and colleagues report in EuroIntervention that the TwinFlo catheter (ThermopeutiX), in pigs, was associated with rapid, selective, deep cerebral hypothermia. They add that the catheter may “offer an improved method for neuroprotection during neurosurgery, cardiac arrest, acute stroke, and other ischaemic insult”. Solar talks [...]
In February, Abbott received FDA Breakthrough Device Designation for a fully implantable left ventricular assist device, Biotronik received the CE mark for its Osiro Mission drug-eluting stent, and BlueGrass Vascular Technologies got a FDA de novo classification order for its Surfacer Inside-Out access catheter system. CE marks CE mark—Fist compression device (Fist Assist Devices) [...]
Hero Access Vascular has announced that it has received clearance from the FDA for the second generation of its HydroPICC peripherally inserted central catheter (PICC), which has demonstrated a thrombus accumulation rate 30 times less than traditional PICCs and the potential to significantly reduce catheter occlusions. PICCs have become an increasingly popular [...]
EOSedge Alphatec Holdings (ATEC) has announced that it has entered into an agreement to acquire EOS imaging for a purchase price of up to US$88 million, plus debt retirement of US$33.9 million, in a combination of cash and equity. EOS imaging is specialist in orthopaedic medical imaging and software solutions. The EOS technology [...]
In January this year, Abbott made history when it became the first company in the world to receive market approval for a transcatheter mitral valve implantation (TMVI) device. Its Tendyne system now has a CE-mark indication for the management of patients with mitral regurgitation who cannot undergo mitral valve surgery or percutaneous edge-to-edge repair [...]
Saket Girotra A review of data from Veteran Health Administration shows that there was a temporal increase in the use of revascularisations for the management of critical limb ischaemia between 2005 and 2014. This increase correlated with a reduction in both mortality and major amputation during the same time period. However, contrary [...]
Film maker David Owens A short film (“Today is a Good Day”), which showcases the work of Aortic Dissection Awareness UK & Ireland, has won the Rare Disease Film Festival’s Peoples’ Choice award. According to Rare Disease UK, the organisers of the event, the film festival is the UK’s first-ever film event to be [...]
Jolanda Kluin (Credit: BHF) A soft robotic heart that is designed to replace the need for a heart transplant is one of four research projects that have made the shortlist for the Big Beat Challenge initiative—organised by the British Heart Foundation—that awards £30m to a project that seeks to identify a real-world [...]
Leonid Sternik Append Medical, with their novel left atrial appendage (LAA) closure device (Appligator), were a finalist in the 2019 ICI Innovation Award Competition (Innovation in Cardiovascular Interventions 2019; 8–10 December, Tel Aviv, Israel). In this commentary, Leonid Sternik who came up with the concept for the device, outlines the need for [...]
Scott Bowen A research project at the University of Leeds aiming to identify new drug treatments for heart failure patients has been awarded a grant of almost £150,000 by British charity Heart Research UK. The project, which will be led by Scott Bowen (University of Leeds, UK), will investigate the causes of [...]
Fist Assist Devices has received the CE mark and has begun marketing the Fist Assist device for vein enhancement and enlargement in the European Union and other countries that recognise the CE mark. According to the press release, Fist Assist is the only wearable, patent-protected, intermittent compression device to increase vein diameter prior to [...]
Cordella Endotronix has announced the enrolment of the first two patients in the PROACTIVE-HF trial. The trial is a premarket investigational device exempt (IDE) study evaluating the safety and efficacy of the Cordella pulmonary artery pressure sensor system (Cordella sensor) for the treatment of heart failure. The first two patients were successfully [...]
BioVentrix BioVentrix has announced that Gregg Stone (Mount Sinai Health System, New York, USA) has signed on as principal investigator of the ALIVE trial of the Revivent TC transcatheter ventricular enhancement system. The system is a hybrid, closed-chest transcatheter procedure designed to treat patients with ischaemic cardiomyopathy by reshaping and restoring the [...]
Cardiovalve has received FDA approval for an early feasibility study of its transcatheter tricuspid valve replacement system for a tricuspid regurgitation indication; the Cardiovalve system also has been granted Breakthrough Device Designation status by the FDA. Cardiovalve commenced its study for tricuspid regurgitation in the USA earlier this year. The study’s primary endpoint is [...]
Appligator Append Medical has announced the clinical proof-of-concept data evaluating the safety of left atrial appendage (LAA) closure through Append’s patented tissue manipulation procedure. A press release says that the procedure serves as a feasibility study for Append’s Appligator minimally invasive LAA closure device, which uses natural tissue manipulation to achieve complete [...]
SuperMap (Acutus Medical) Acutus Medical has announced FDA clearance of SuperMap, which a press release calls a revolutionary addition to the company’s AcQMap 3D imaging and mapping system. It adds that SuperMap is a high-fidelity, high-resolution mapping algorithm for both stable and transient arrhythmias. Furthermore, SuperMap’s user interface effortlessly guides electrophysiologists to [...]
Gallant Abbott has received the CE mark for the new Gallant implantable cardioverter defibrillator (ICD) and cardiac resynchronisation therapy defibrillator (CRT-D) devices, which—a press release reports—have the most advanced heart rhythm management capabilities along with a new set of benefits to people in Europe with abnormal heart rhythms and heart failure. The [...]
Medtronic has announced its acquisition of Digital Surgery, which is a privately-held pioneer in surgical artificial intelligence (AI), data and analytics, and digital education and training. A press release says that the acquisition will strengthen the Medtronic robotic-assisted surgery platform and has applicability for the Medtronic broader portfolio. The terms of the agreement have [...]
Huw Jones Rexgenero has announced that Huw Jones has joined the company’s board as a non-executive director, and will chair the company’s remuneration committee. This follows the recent appointment of David Horn Solomon as chairman of Rexgenero’s Board. Huw is currently CEO of Chronos Therapeutics Limited (Chronos), a spin out from the [...]
CorWave, a medtech company focused on the development of an innovative left ventricular assist device (LVAD), has announced today the election of Jim Schuermann to its board of directors. A press release states that Schuermann was instrumental in transforming HeartWare—a LVAD start-up valued around $100M when he joined—into a $Bn Nasdaq-listed company. As senior [...]
Bluegrass Vascular Technologies (BVT) has announced that the FDA has granted a de novo classification order for its Surfacer Inside-Out access catheter system. A press release reports that the Surfacer system is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions [...]
HeartHero The American College of Cardiology (ACC) and HeartHero have formed an alliance to make a significant impact on survival rates after sudden cardiac arrest and further ACC’s mission to transform cardiovascular care and improve heart health through HeartHero’s portable automated external defibrillator (AED) technology. While ACC is involved in other innovation [...]
Metactive Medical has changed its name to Artio Medical, effective immediately. Artio Medical was founded in 2014 as a small research and development group focused on developing metal implants for vascular embolisation. The organisation has since grown to include a team, according to a press release, of exceptionally talented medical device professionals and expanded [...]
Xeltis valve A press release reports that clinical trial results of Xeltis pulmonary valve show promising functionality of the living valves, which is developed in patients as a result of its restorative implants. The data were presented at the International Conference of Tissue-Engineered Heart Valves (ICTEHV) as part of the 2020 Heart [...]
Orsiro Mission Biotronik now has the CE mark for its Orsiro Mission drug-eluting stent system. According to a press release, the next-generation of the company’s ultrathin strut Orsiro drug-eluting stent provides higher deliverability than other contemporary stents. The press release states that the Orsiro Mission “has a completely re-engineered delivery system to [...]
Caption guidance Caption Health has announced that the FDA has authorised marketing of Caption Guidance software, which is designed to assist medical professionals in the acquisition of cardiac ultrasound images. The system uses artificial intelligence (AI) to provide real-time guidance and diagnostic quality assessment of images. The aim is to empower healthcare [...]
XableCath has announced that its XableCath Crossing catheters have received CE mark for peripheral use. Its crossing devices will be available for sale in Europe in two versions, a blunt tip and an abrasion tip, in a variety of diameters and lengths. XableCath received US Food and Drug Administration (FDA) clearance for its crossing [...]
Mamas Mamas A project at the University of Manchester (UK) that is aiming to develop a new tool for predicting the risk of a cardiovascular event or death in patients who have had a myocardial infarction has received a grant of almost £150,000 from national charity Heart Research UK. The project, which [...]
Medtronic has said it will begin enrolment in a pilot study evaluating the safety and efficacy of the Symplicity Spyral renal denervation system using a targeted procedural approach with a reduced number of radio frequency ablations. Set to enrol 50 patients at up to 15 sites in the USA and Europe, the single-arm study [...]
Laminate Medical Technologies has announced the completion of enrolment into the VasQ External Support US study. The study was conducted at 17 sites across the USA and prospectively enrolled 144 male and female patients in need of an arteriovenous fistula (AVF) for haemodialysis. Both brachiocephalic and radiocephalic AVF patients were included in the study. [...]
The FDA has granted Breakthrough Device Designation for the Aria CV pulmonary hypertension system (Aria CV PH System). A press release reports that Aria has already performed a successful acute first- in-human clinical study in Vienna, Austria, and is now preparing for a US clinical trial under the FDA’s early feasibility study programme to [...]
Patrick M McCarthy Last month, Abbott announced that that the FDA has approved a new trial—REPAIR MR—to evaluate the safety and efficacy of percutaneous edge-to-edge repair (MitraClip) for the management of patients with primary mitral regurgitation at moderate surgical risk. Currently, in both Europe and the USA, MitraClip has market approval for [...]
Robert Kormos The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Abbott for its in-development fully implantable left ventricular assist system (FILVAS). The FDA Breakthrough Device Designation programme will allow, according to Robert L Kormos (medical director for mechanical circulatory support at Abbott), the company to “fast track” [...]
Rhythm AI has announced the signing of a research collaboration agreement with Biosense Webster. A press release outlines that the agreement grants Rhythm AI access to certain data from the Biosense Webster CARTO 3 system to support a multicentre clinical trial of its STAR Mapping system. STAR Mapping is a new, AI driven mapping [...]
The charity Heart Research UK is donating more than £100,000 to a project, led by Paolo Madeddu (chair of Experimental Cardiovascular Medicine, the University of Bristol, Bristol, UK), that is developing a new treatment, BACH1 inhibitors, for stimulating the growth of new blood vessels in the heart. Paolo Madeddu et al previously found that [...]
MedAlliance has announced that it now has the CE mark for the Selution SLR—a sirolimus drug-eluting balloon for the treatment of peripheral arterial disease. This approval applies to sizes from 2x20mm to 7x150mm. According to a press release, this award was supported by two-year results from the SELUTION SLR first-in-human study, which involved 50 [...]
ELVes Radial 2ring Pro fibre Biolitec has added another laser fibre to its ELVeS Radial 2ring laser fibre portfolio. A press release reports that the newly developed ELVeS Radial 2ring Pro enables the minimally invasive endovenous laser treatment of severely tortuous veins. It adds that the ELVeS Radial 2ring Pro fibre has [...]
Cobalt ICD Medtronic has received the CE mark for its Cobalt and Crome portfolio of implantable cardioverter-defibrillators (ICD) and cardiac resynchronisation therapy-defibrillators (CRT-D). With the launch of the Cobalt and Crome platform, Medtronic also is making TriageHF technology available. A press release reports that this technology assesses patients’ heart failure risk through [...]
AccuCinch The FDA has approved an expansion of enrolment of the CorCinch HFrEF early feasibility study, which is evaluating the AccuCinch ventricular repair system (Ancora Heart) for the management of patients with reduced ejection fraction heart failure (HFrEF). This expansion allows Ancora Heart to double patient enrolment from 15 to 30 patients and [...]
Admedus has announced the complete transfer of its sterilisation method as part of its Adapt tissue treatment process to 4C Medical. As per the Admedus supply agreement with 4C Medical, 4C Medical will pay an additional $US1 Million ($US 0.44M previously received) to use the technology to sterilise the Adapt tissue incorporated in its transcatheter [...]
Mark Peretti Gore’s augmented reality (AR) experience app, which is available on both Apple and Android platforms, provides interactive 3D holograms of the company’s endovascular devices, such as the Excluder conformable abdominal aortic aneurysm (AAA) endoprosthesis, and is designed to be used as a high-res, anatomically correct visual aid that can be [...]
Stéphan Haulon At the 2020 Controversies and Updates in Vascular Surgery meeting (CACVS; 23–25 January, Paris, France), Stéphan Haulon (Hôpital Marie Lannelongue, Groupe Hospitalier Paris Saint Joseph; Université Paris Saclay, Paris, France) reported that an artificial intelligence (AI) based system for aortic diameter and volume assessment (ARVA, Incepto Medical) had a preliminary [...]
Vascular Therapies has announced the closing of an upsized $17.3 million private financing. A press release reports that the financing comprised existing and new investors, and was increased from an originally targeted $15 million up to $17.3 million—based upon interest from new investors, including a strategic foreign healthcare company. It adds that Vascular Therapies [...]
The Tendyne transcatheter mitral valve implantation (TMVI) system (Abbott) has received the CE mark, making Abbott the first company to have such a device on a market anywhere in the world. A press release reports that this “life-changing” therapy treats significant mitral regurgitation in patients requiring a heart valve replacement and provides a safe [...]
This month, Medtronic has received FDA approval for its Micra AV system and for its Stealth Autoguide system. Also, the FDA gave the company the nod to proceed with an investigational device exemption (IDE) trial to evaluate a pulsed field ablation (PFA) system. Other approvals in January include a FDA green light for a [...]
A press release reports that the FDA has cleared a suite of algorithms that, when combined with Eko’s digital stethoscopes, will enable healthcare providers in the USA to more accurately screen for heart conditions during routine physical exams. If left undiagnosed, these heart conditions can lead to stroke and heart failure. According to the [...]
Vivek Reddy At the AF Symposium 2020 (23–25 January, Washington, DC, USA), Vivek Y Reddy (Helmsley Electrophysiology Center, Icahn School of Medicine at Mount Sinai, New York, USA) reported that pulsed field ablation (PFA)—with the Farawave (Farapulse Inc.) catheter—may be a feasible and safe approach for treating patients with persistent atrial fibrillation [...]
Vesalius Cardiovascular has announced the successful completion of its first 30-day chronic animal study using its mitral valve repair device. The predetermined endpoints of the study were the absence of device or valve thrombosis and the absence of leaflet injury due to the device, and both endpoints were robustly confirmed upon completion of the [...]
David Hayes Biotronik has announced the appointment of David Hayes as chief medical officer. A press release reports that Hayes will oversee the development of the company’s cardiovascular solutions with a focus on advancing unique, proven innovations that help physicians and health systems deliver on their commitment to patient care. The press [...]
Nilesh Samani UK charity The British Heart Foundation (BHF) has announced its shortlist of four research projects competing for its Big Beat Challenge; a global competition, launched in August 2018, that is offering a single research award of up to £30m. The aim of the competition is to push the international research [...]
BioVentrix BioVentrix has received an extension of its CE mark for the Revivent TC transcatheter ventricular enhancement system to May 2024. The company received its initial CE mark in 2016. Less invasive ventricular enhancement (LIVE) therapy uses the Revivent TC system to exclude scar tissue on the left ventricle that has occurred [...]
Teleflex has received 510(k) clearance from the FDA for its Wattson temporary pacing guidewire. A press release reports that this is the first commercially available bipolar temporary pacing guidewire designed specifically for use during transcatheter aortic valve implantation (TAVI) and balloon aortic valvuloplasty. It adds that this “innovative device” offers clinicians a 0.035” pigtailed [...]
Medtronic has received FDA approval of Micra AV, which a press release describes as “the world’s smallest pacemaker with atrioventricular (AV) synchrony”; the pacemaker is indicated for the treatment of patients with AV block. The press release states that Medtronic “now offers the first and only FDA-approved leadless pacemaker portfolio, expanding the number of [...]
FEops has announced that the first patient has been enrolled in the physician-initiated PREDICT-LAA trial. The trial, which is led by Righshospitalet (Copenhagen, Denmark), aims to assess whether the use of FEops HEARTguide computer simulations (based on cardiac CT imaging) can contribute to better preprocedural planning and improved procedural outcomes of percutaneous left atrial appendage [...]
Opsens has received 510(k) clearance from the FDA to market its OptoWire III, a coronary pressure guidewire for physiological measurements such as fractional flow reserve and diastolic pressure ratio (dPR). According to a press release, the OptoWire III is the latest version of OptoWire and the OptoWire family of products are used to diagnose [...]
Morph DNA BioCardia has announced that the FDA has granted 510(k) clearance for the Morph DNA deflectable guide catheter, which is used to guide the Helix biotherapeutic delivery system during CardiAMP cell therapy delivery in the heart. The Morph DNA deflectable guide catheter, a press release reports, is designed to enhance procedural [...]
Source: BIBA MedTech Insights TAVI Tracker The TAVI market in Western Europe grew by 19.2% between Q3 2018 and Q3 2019. Over the last three years, Edwards Lifesciences (the market leader) lost market share while Medtronic and Boston Scientific both gained market share. Boston Scientific’s acquisition of Symetis in Q2 2017 helped [...]
Jennifer Radin A study in The Lancet suggests that de-identified data from activity and physiological trackers (such as a Fitbit) could be used to provide information on flu outbreaks. Authors Jennifer M Radin (Translational Institute, Scripps Research, La Jolla, USA) and others explain that this information “could be vita to enact timely [...]
Malcolm Finlay Johnny, a 72-year-old film producer, is meeting clients when his watch gently vibrates notifying him of his irregular pulse. He pressed his finger to his strap, and with a swipe sends the single lead ECG to his cardiologist without pausing the meeting. The artificial intelligence (AI) delivered backbone powering self-diagnostics [...]
A yellow box indicates where an AI system found cancer hiding inside breast tissue (NorthWestern University) Scott Mayer Mckinney (Google Health, Palo Alto, USA) and colleagues report in Nature that an artificial intelligence (AI) system was superior to human experts in predicting breast cancer (based on mammograms). They add that the findings [...]
Cagent Vascular has announced the initiation of the PRELUDE-BTK study. According to a press release, the purpose of this prospective, single-arm, multicentre feasibility study is to show the safety and efficacy of the Serranator percutaneous transluminal angioplasty (PTA) serration balloon catheter in infrapopliteal arteries. Andrew Holden (University of Auckland, Auckland Hospital, Auckland, New Zealand) [...]
MedAlliance has now been granted FDA Breakthrough Device Designation status for its Selution sustained limus release (SLR) sirolimus-eluting balloon for an arteriovenous fistulae indication. The company has previously received similar status for the coronary in-stent restenosis and peripheral below-the-knee indications of the balloon. According to a press release, Selution’s technology involves unique micro-reservoirs made [...]
Intellis Medtronic has acquired Stimgenics, which a press release reports has pioneered a novel spinal cord stimulation (SCS) waveform known as “differential target multiplexed” (DTM) spinal cord stimulation. The press release adds that the therapy, which is delivered via the Medtronic Intellis platform, is a new and unique programming option to treat [...]
The FDA has approved a new alternative surgical technique for the HeartMate 3 heart pump (Abbott) that will allow more advanced heart failure patients to avoid open heart surgery. The new, less invasive approach is designed to provide surgeons a choice in surgical method for patients receiving the HeartMate 3 left ventricular assist device [...]
WEB aneurysm embolisation system MicroVention (Terumo) has received FDA premarket approval (PMA) for the WEB aneurysm embolisation system for the treatment of intracranial wide neck bifurcation aneurysms. A press release states that the WEB system is the first and only PMA-approved device in the new category of intrasaccular flow disruptors for aneurysm [...]
Titan Medical and Cambridge Design Partnership (CDP) has announced an expanded engagement in respect of the instrument development programme for Titan’s single-port robotic surgical system. Additionally, CDP has subscribed for common shares of Titan. David McNally, president and CEO of Titan, says: “We are pleased to announce our expanded engagement of CDP, and welcome [...]
TriNav TriSalus Life Sciences has launched its TriNav infusion system (TriNav). Powered by its proprietary pressure-enabled drug delivery (PEDD) approach with SmartValve technology, according to a press release, TriNav is designed to help overcome the infusion barriers that limit therapeutic uptake in solid tumours, including hepatocellular carcinoma and liver metastases. The press [...]
JenaValve JenaValve Technology has received “Breakthrough Device” designation from the FDA. This designation is for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. The company is the sponsor of a US investigational device exemption (IDE) trial and is conducting a multicentre clinical programme for the treatment of patients with [...]
MitraClip XTR The FDA has approved a first-of-its-kind clinical trial that will compare the effectiveness of Abbott’s minimally invasive MitraClip device with open heart mitral valve surgical repair in people with primary mitral regurgitation who are eligible for open-heart surgery. If successful, a press release states, the trial has the potential to [...]
Penumbra has announced FDA 510(k) clearance for expanded indication of its Indigo aspiration system. As part of the system, Indigo aspiration catheters and separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and now for the treatment of pulmonary embolism. Penumbra introduced [...]
Alucent Biomedical has received FDA approval to proceed with a phase 1 clinical trial to evaluate the safety and efficacy of its revolutionary Natural Vascular Scaffolding (NVS) technology. The therapy is designed to treat peripheral arterial disease of the lower extremities. The Alucent NVS vessel restoration system with photoactivated linking combines standard angioplasty with [...]
Reflow Medical announced that its Temporary Spur stent system—novel retrievable stent technology intended for the treatment of below-the-knee peripheral arterial disease—has been designated for the Breakthrough Devices Program by FDA. The Temporary Spur stent system is a novel combination device that consists of consisting of a retrievable stent system. The system has a series [...]
The FDA has cleared the Stealth Autoguide system (Medtronic), which a press release reports is the first cranial robotic platform to integrate with Medtronic’s enabling technology portfolio to create an end-to-end procedural solution. The Stealth Autoguide Platform is a robotic guidance system intended for the spatial positioning and orientation of instrument holders or tool [...]
Life Spine has received FDA clearance to market its titanium stand-alone anterior lumbar interbody fusion (ALIF) spacer system. The system comes in footprints of 34mm x 24mm, 38mm x 28mm and 42mm x 30mm. Additionally, there are three lordotic options of 6 degrees, 12 degrees and 18 degrees and heights ranging from 11mm to [...]
Matthew K Harbaugh has been appointed as executive vice president and chief financial officer (CFO) of NuVasive. Harbaugh succeeds Rajesh (Raj) J Asarpota, who will transition from the company. A press release reports that Harbaugh brings more than 25 years of experience in finance, business and strategy, and operations management. As CFO, Mr. Harbaugh [...]
Jean-Claude Dubacher B Braun has announced the appointment of Jean-Claude Dubacher as chairman and CEO. Dubacher joined B Braun on 1 August 2019 as president, B Braun Medical. A press release reports that Dubacher’s experience in the healthcare industry spans more than 15 years in consulting and corporate roles, including strategy, commercial, [...]
Fujifilm has entered into an agreement with Hitachi to acquire the latter’s diagnostic imaging-related business to further expand its Healthcare business. Prior to the acquisition, Hitachi will establish a company and implement an absorption-type company split whereby the new company will absorb the business. Under the share purchase agreement between Fujifilm and Hitachi, according [...]
Eko DUO digital stethoscope Eko has announced that the FDA has granted the company breakthrough status for its ECG-based algorithm that is designed to provides easily accessible screening test for heart failure. A press release reports that the algorithm analyses 15 seconds of ECG data collected from the Eko DUO digital stethoscope during [...]
David Hale Guerbet’s Board of Directors has announced that David Hale has been appointed as the company’s CEO. According to a press release, chief commercial officer and group executive committee member since February 2018, David Hale takes over the position from Yves L’Epine, who has been CEO since end of 2011. For [...]
Peter Pizzo ControlRad, which is focused on reducing unnecessary radiation exposure during fluoroscopically guided procedures (FGP), has announced several additions to its leadership team. Joining are Peter Pizzo as chief financial officer, Amy Lazarus as vice president of USA operations, Joe Ross as vice president of marketing, and Sean Finnerty and Tim [...]
Each month, BIBA Briefings compiles a list of market approvals (European or US), FDA Device Designations, and recalls. For example, in December 2019, Cryolife received CE marks for two stent grafts (E-nya and E-nside), EOS imaging received 510(k) clearance from the FDA for its new generation imaging system (EOSedge), and Aleva Neurotherapeutics was awarded [...]
Thrombolex has received FDA clearance for its Bashir endovascular catheter—Short Basket (BEC S-B). The indication for use of the BEC S-B is for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. A press release reports that Thrombolex provides an innovative line of endovascular catheters, which feature a unique [...]
DirectSTIM Aleva Neurotherapeutics has been awarded the CE mark for its—a press release reports—flagship product, the directSTIM deep brain stimulation (DBS) system. According to the press release, Aleva’s revolutionary DBS system incorporates directional electrode technology and is designed to be more precise and efficient, with optimised stimulation that will potentially reduce side [...]
Sapien 3 Edwards Lifesciences has received the CE mark for its Sapien 3 transcatheter aortic valve implantation (TAVI) device to be used to manage aortic stenosis in low-risk patients. Both Edwards and Medtronic (with its CoreValve Evolut range) have FDA approval for their devices to be used for low-risk patients in the [...]
Julian Paton Erin O’Callaghan (School of Physiology, Pharmacology and Neuroscience, Biomedical Science, University of Bristol, Bristol, UK) and others report in the Journal of Physiology that enhancing respiratory sinus arrhythmia (RSA) improved cardiac function in rats with induced heart failure. They note that this finding gives a “tantalising demonstration of the physiological [...]
Miguel Angel Cobos Gil Miguel Angel Cobos Gil (Instituto Cardiovascular, Hospital Clinico San Carlos, Madrid, Spain) outlines in Annals of Internal Medicine a novel method of using the Apple Watch to record a multilead, quasi-standard ECG. He reports that the method is feasible but that a “broad range of clinical studies are [...]
R-One Robocath has announced it has successfully completed six robotic coronary angioplasties with R-One, which a press release says is a first for the continent of Africa. Faizel Lorgat (Netcare Christiaan Barnard Memorial Hospital, Cape Town, South Africa) performed the percutaneous coronary intervention (PCI) procedures as part of a distribution agreement with [...]
The FEops team FEops has been awarded a grant of €3.2m from the European Innovation Council (EIC) accelerator programme. The grant, a press release reports, will accelerate the clinical evidence gathering and business implementation of FEops HEARTguide predictive preoperative planning for transcatheter structural heart interventions on a worldwide scale. According to the [...]
Imperative Care has completed the initial closing of a Series C financing of $85m to support the commercial launch of its portfolio, which is composed of the latest advances in neurovascular devices treating ischaemic and haemorrhagic strokes. The round was co-led by new investors Ally Bridge Group and Bain Capital Life Sciences. A press [...]
Cardiologs has earned Frost & Sullivan’s New Product Innovation Award. The cloud-based artificial intelligence (AI) solution was recognised for its ability to analyse ambulatory ECG recordings faster and more reliably than traditional software, enabling clinicians to provide accurate, timely, and cost-effective arrhythmia diagnosis. A press release reports that Cardiologs was launched in North America [...]
Philips and Paige have announced a strategic collaboration to deliver clinical-grade artificial intelligence (AI) applications to pathology laboratories. These AI technologies, starting with Paige Prostate, aim to help pathologists identify, quantify and characterise cancer in tissue samples and make precise diagnoses more efficiently. This may, ultimately, positively impact pathologist’s workflow and treatment planning for [...]
Eyal Lifschitz Peregrine Ventures just closed its fourth fund—Peregrine 4—raising $115 million. Their partners include some of the leading institutional and private equity investors from Israel, the USA, Europe and Australia. According to a press release, Peregrine now has more than $200 million under management and has an equal amount available for [...]
LAA closure Append Medical is to present a novel left atrial appendage (LAA) closure device—designed to minimise stroke risk in patients with atrial fibrillation patients—at the ICI Innovation Award Competition, which takes place at the 2019 Innovation in Cardiovascular Interventions (ICI) (8–10 December, Tel Aviv, Israel). A press release reports that the [...]
Max Y Emmert At the 2019 European Association of Cardio-Thoracic Surgeons (EACTS) annual meeting (3–5 October, Lisbon, Portual), Max Y Emmert (Institute for Regenerative Medicine, University of Zurich, Switzerland/the Department for Cardiothoracic and Vascular Surgery, German Heart Center Berlin and Charite Berlin, Germany) received the Techno-College Innovation Award for the LifeMatrix, a [...]
Sapien 3 and CoreValve Evolut Pro According to two studies published in Circulation, the balloon-expandable Sapien (Edwards Lifesciences) transcatheter aortic valve implantation (TAVI) system is associated with lower mortality than is the self-expanding CoreValve (Medtronic) system. These findings have led to calls for randomised head-to-head trials comparing the two devices. In their [...]
Andrew Holden Recently, the FDA approved Medtronic’s paclitaxel-coated balloon IN.PACT AV for the management of failing arteriovenous fistulae (AVF). Approval for the device was based on data from the IN.PACT AV Access trial, which showed the device to significantly increase primary patency compared with standard percutaneous transluminal angioplasty. Andrew Holden (Department of [...]
Source: BIBA MedTech LAA Monitor (quarterly) Data from the CAP and CAP2 registries—which contain the longest and largest follow-up of patients—add to previous evidence that left atrial appendage closure (LAAC) with Watchman (Boston Scientific) is a safe and effective alternative to long-term anticoagulation in patients with atrial fibrillation. Furthermore, the results show [...]
Maurizio Taramasso Maurizio Taramasso (Department of Cardiac Surgery, University Hospital of Zurich, University of Zurich, Zurich, Switzerland) and colleagues write in EuroIntervention that transcatheter mitral valve repair and transcatheter mitral valve replacement (TMVR) “will most likely be complementary rather than competitive” therapies, adding that a “repair-first” (followed by TMVR if needed) “seems [...]
VivaLNK VivaLNK has received a Class IIa medical device CE mark for its multivital medical wearable sensor and software development kit (SDK). According to a press release, at only 7.5grams, the reusable patch is the smallest of its kind. The press release states that the patch’s reusability factor can increase the economic [...]
i:X MolecuLight has received FDA 510(k) clearance for its i:X handheld fluorescence imaging device for use in the detection of wounds containing bacteria. This FDA 510(k) clearance is an expansion of the original de novo clearance for the MolecuLight i:X platform, which was granted 14 August 2018. A press release reports that [...]
InnovHeart—a developer of novel transcatheter mitral valve replacement (TMVR) systems—has appointed medical device entrepreneur J Brent Ratz as non-executive independent member of its Board of Directors. A press release reports that Ratz has more than 19 years of experience in the medical device industry. He is currently co-founder and managing director of inQB8 Medical [...]
Image credit: Rexgenero The first UK clinical trial site for the treatment of diabetic patients with chronic limb-threatening ischaemia using a novel patient-specific regenerative therapy has opened for patient recruitment at the University Hospital of Wales in Cardiff. The site will be evaluating REX-001 (Rexgenero) in two phase III trials codenamed the [...]
E-nside CryoLife has received two CE marks, with one for the E-nside thoracoabdominal aortic aneurysm stent graft and one for the E-nya thoracic stent graft system. Two press releases announcing the CE marks, respectively, report that E-nside is the company's newest proprietary endovascular stent graft for patients with thoracoabdominal aortic disease and [...]
GE Healthcare and Affidea have signed a multiyear agreement to deploy imaging and digital technologies across the Affidea network. According to a press release, GE Healthcare will install 200+ new equipment in Affidea’s network of centres across Europe. The press release states that the deal includes the provision of 60 new MRIs, 50 ultrasound [...]
Philips stroke workflow Philips has announced a major clinical trial to assess the impact of a “direct to angio suite” workflow on stroke patient outcomes. The study will assess the role of Philips’ advanced image-guided therapy platform to diagnose, plan and treat stroke patients in the interventional suite without requiring an initial [...]
Novartis has entered into an agreement and plan of merger with The Medicines Company to acquire the US-based biopharmaceutical company for $85 per share in cash, valuing the company at approximately $9.7 billion on a fully diluted equity basis. The offer price represents a premium of approximately 41% over The Medicines Company’s 30-day (to [...]
Judith S Hochman The largest trial to date to compare revascularisation with a conservative strategy in patients with stable ischaemic heart disease has found no additional benefit a median of three years after the procedure. Data from the ISCHEMIA trial were presented at a late-breaking trial session at the American Heart Association Scientific [...]
GE Healthcare GE Healthcare has launched the Edison Developer Program with the aim of accelerating the adoption and impact of intelligent applications and developer services across health systems. The programme is based on Edison, GE Healthcare’s intelligence platform, and is designed to help healthcare providers gain easier access to market-ready algorithms and [...]
EOSedge EOS imaging has received 510(k) clearance from the FDA for its new generation imaging system, EOSedge. Receipt of FDA 510(k) clearance follows the recent commercial launch of EOSedge in Europe, Canada and Australia. A press release reports that EOSedge is the first general X-ray system powered by a high-resolution photon counting [...]
i-FACTOR The FDA has granted Cerapedics a premarket approval (PMA) supplement for its i-FACTOR peptide enhanced bone graft in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease. Cerapedics requested approval for an updated package insert that incorporates the 24-month follow-up data from patients enrolled in the [...]
Skope Clip-on Camera Canon Medical has concluded a contract to acquire all shares of Skope Magnetic Resonance Technologies. With a unique research and development team, a press release reports, Skope is a company devoted to providing MRI users with unprecedented imaging quality and performance. The acquisition of Skope was completed according to [...]
Alphatec Holdings has announced the commercial release of the SafeOp Neural InformatiX system, which has been designed to seamlessly integrate critical neural information into ATEC procedural solutions. The system has been engineered to provide surgeons with actionable information regarding both the location and the health of nerves at risk during surgery. Specifically, the SafeOp [...]
Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe, the USA, and other markets. It also covers recalls, safety notices, and indication withdrawals. This report (Monday 18 October to Friday 22 November) features FDA approval for IN.PACT AV, a recall for a guidesheath, and FDA Breakthrough Device Designation for [...]
Wrapsody Merit Medical has been granted Breakthrough Device Designation by the FDA for the Wrapsody endovascular stent graft system. A press release reports that the Wrapsody system is a flexible, self-expanding endoprosthesis for which Merit intends to seek indication for use in haemodialysis patients for the treatment of stenosis within the central veins [...]
EchoGo Ultromics has received 510(K) clearance from the FDA for its image analysis system, EchoGo Core. According to a press release, the clearance is a major milestone for Ultromics and enables the business to make EchoGo available to clinicians and healthcare providers in the USA. EchoGo applies artificial intelligence (AI) to automate [...]
Terumo has decided to acquire Aortica corporation, which is a US-based company dedicated to advancing the science of personalised vascular therapy. Aortica has developed an automated case planning software known as “AortaFit”, which is designed to precisely match fenestrations on an endograft with the unique locations of each individual patient’s branch arteries during fenestrated [...]
IN.PACT AV Medtronic has announced FDA approval of its IN.PACT AV drug-coated balloon—a paclitaxel-coated balloon indicated for the treatment of failing arteriovenous access in patients with end-stage renal disease (ESRD) undergoing dialysis. According to a press release, randomised trial results from the IN.PACT AV Access trial show that IN.PACT AV drug-coated balloon [...]
Somatom X.cite Siemens Healthineers presents its new Somatom X.cite single-source CT scanner, together with the new myExam Companion user guiding system, based on artificial intelligence (AI). According to a press release, the intelligent user guidance system guides the user through the workflow using specific questions. This user interface, and the latest scanner [...]
A press release reports that LivaNova is to discontinue its Caisson transcatheter mitral valve replacement programme and will undertake a restructuring of its heart valve business to improve profitability and ensure business continuity. It adds that LivaNova’s heart valve business line represented nearly $130 million in revenue for full-year 2018 and has experienced a [...]
Life Spine has received clearance from the FDA to market the Longbow titanium lateral expandable spacer system. A press release reports that system is available in lengths ranging from 45mm to 60mm, heights from 9mm to 15mm, 0 degrees and 7 degrees lordotic options and widths that expand from 15mm to 27mm anterior to [...]
Revivent TC The FDA has granted Breakthrough Device Designation status for its Revivent TC transcatheter ventricular enhancement system (BioVentrix) for heart failure. A press release reports that the less invasive ventricular enhancement (LIVE) procedures uses Revivent TC System to exclude scar tissue on the left ventricle that has resulted from a myocardial [...]
S Jay Mathews The TASTE and TOTAL studies suggested that routine thombus aspiration in patients undergoing percutaneous coronary intervention (PCI) did not provide mortality benefit and may increase the risk of stroke. However, a new study (CHEETAH) is evaluating whether a next-generation aspiration catheter could lead to improved outcomes. S Jay Mathews [...]
Richard Houlihan For those involved in the MedTech industry, unless you have been living under a rock, you will know about the new European medical device regulation (MDR). Furthermore, you will know that Eudamed is at the core of the MDR. However, to recap, MDR-Eudamed is where specific medical device economic operators [...]
Edwards Lifesciences has issued a recall for the guidesheath (model number: 10000GS and 10000GSCE) that is used in conjunction with the Pascal system for the transcatheter repair of mitral valve regurgitation. According to a letter sent to physicians, there is a potential for damage to the inner liner of the guidesheath because of a [...]
Miles D White will be stepping down, after 21 years, as CEO of Abbott on 31 March 2020. According to a press release, White’s tenure is the second longest for a non-founder in today’s S&P 100; he will remain executive chairman of the Board. The Board has unanimously appointed Robert B Ford—a 23-year Abbott [...]
Mixed Reality Viewer Brainlab has launched the Mixed Reality Viewer, which is designed to bring spatial computing into daily clinical practice for surgical plan review, medical student training and patient consultation. A press release reports that the Mixed Reality Viewer uses the head-mounted display Magic Leap One (from Brainlab strategic development partner [...]
CorPath GRX Corindus, now part of Siemens Healthineers, has completed the first multi-city, transcontinental percutaneous coronary intervention (PCI) simulations in the USA over three network connection types: 5G wireless, dedicated fibre, and commercial public internet networks. A press release reports that Ryan Madder (Frederik Meijer Heart & Vascular Institute, Spectrum Health, Grand [...]
Data presented at the 2019 American Heart Association Scientific Sessions (16–18 November, Philadelphia, USA), a press release reports, confirm the accuracy and safety of the Cordella pulmonary artery (PA) pressure sensor system (Cordella Sensor, Endotronix). The PA sensor system, with the Cordella system, is designed to proactively deliver the information necessary to improve heart [...]
InVivo Therapeutics has appointed Robert J Rosenthal to the company’s Board of Directors, effective 8 November 2019. According to a press release, Rosenthal brings more than 25 years of experience to the InVivo Board as an accomplished executive and business leader in the biotechnology, therapeutics and medical device industries. With the addition of Rosenthal, [...]
Paige has received the CE mark for Paige Prostate, which a press release reports is a first-in-class prostate cancer detection solution. Along with Paige Insight, an artificial intelligence (AI) native digital pathology viewer, Paige Prostate is designed for primary diagnosis. The press release states that these solutions are vendor neutral and allow for seamless [...]
Aktiia blood pressure monitor According to a study in the peer-reviewed journal Blood Pressure Monitoring, a wrist-based optical blood-pressure monitor could be used for ambulatory blood pressure monitoring—removing the need for a cuff-based monitoring system. According to a press release, the novel system (Aktiia) uses the same sensors that are used in [...]
Fitbit has entered into a definitive agreement to be acquired by Google for $7.35 per share in cash, valuing the company at a fully diluted equity value of approximately $2.1 billion. A press release reports that Fitbit pioneered the wearables category by delivering innovative, affordable and engaging devices and services. It adds that Fitbit [...]
Shockwave Lithotripsy Shockwave Medical has announced that it has initiated the DISRUPT CAD IV study of is intravascular lithotripsy (IVL) system for the management of in heavily calcified coronary arteries, with the intention of using data from the study to supporting regulatory device approval in Japan. Shigeru Saito (Shonan Kamakura General Hospital, [...]
Life Spine has entered into a settlement agreement with the USA government that successfully resolves all of the government’s claims. As part of the agreement, it will pay $5.5 million to the US government which noted historical shortcomings in its compliance programme. A press release reports that the company has made significant progress formalising [...]
Senza Omnia Nevro has received approval from the FDA for the Senza Omnia spinal cord stimulation (SCS) system. A press release reports that the Omnia system is the first and only SCS system designed to deliver Nevro’s proprietary HF10 therapy in addition to all other available SCS frequencies. The Omnia system is [...]
Valfix Medical has announced the issuance of US Patent No. 10,463,486 (5 November 2019). According to a press release, this is the second US patent granted for Valfix and was approved only two years and nine months since its priority date. This new patent provides an additional layer of protection for Valfix’s transcatheter repair [...]
Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe, the USA, and other markets. It also covers recalls, safety notices, and indication withdrawals. This report (Monday 28 October to Friday 1 November) features a CE mark approval for Vascade MVP (Cardiva Medical), FDA Breakthrough Device Designation for Surmodics' Sundance [...]
Harel Gadot XACT Robotics has announced that its first robotic system was cleared to market in the USA for use during computed tomography (CT) guided percutaneous interventional procedures. A press release states that XACT’s technology is the “first hands-free robotic system combining image-based planning and navigation with insertion and steering of various [...]
Surmodics has announced that the FDA has designated its Sundance sirolimus-coated balloon (SCB) catheter as a Breakthrough Device under the agency’s Breakthrough Devices programme. The FDA has already designed the sirolimus devices MagicTouch (Concept Medical), Virtue sirolimus-eluting balloon (Orchestra BioMed), and Selution sustained limus release (MedAlliance) as Breakthrough Devices. The Sundance SCB has been [...]
The Chinese National Medical Products Administration has granted market approval to Biotronik’s sirolimus-eluting Orsiro stent. A press release reports that the company expects to make the device, which has a biodegradable polymer, available to Chinese patients and physicians in the coming months. As the second largest drug-eluting stent market in the world, China is [...]
Medtronic has received Breakthrough Device Designation from the FDA for a novel implantable left ventricular assist device (LVAD) for patients with advanced heart failure. A press release reports that, rather than the current LVAD systems that require a driveline cable that extends outside the body to a controller, the future system is designed to [...]
Valiant Navion Medtronic has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its Valiant Navion thoracic endovascular aortic repair (TEVAR) system. Consequently, the company has launched the system in Japan for minimally invasive repair of thoracic descending aortic aneurysms and complicated type B aortic dissections. According [...]
Optimizer Smart Impulse Dynamics, developer of the Optimizer Smart system for delivering cardiac contractility modulation (CCM) therapy, has received FDA approval of a PMA supplement for its next generation, two-lead Optimizer Smart system for the treatment of heart failure. According to a press release, the Optimizer Smart system offers a new therapy [...]
One Click MRI HeartVista has received 510(k) clearance from the FDA for its artificial intelligence (AI) assisted One Click MRI acquisition software for cardiac exams. A press release reports that with HeartVista’s solution, cardiac MRI is now simple, time-efficient, affordable, and highly consistent. It adds that, prior to the HeartVista system, the [...]
Vascade MVP Cardiva Medical has received the CE mark for its Vascade MVP venous vascular closure system. Additionally, the AMBULATE study has been published in JACC: Clinical Electrophysiology. According to a press release, the AMBULATE study demonstrates the safety and efficacy of the system compared with manual compression. The press release adds [...]
KardiaMobile AliveCor and Huami have come together to create a multi-faceted global strategic alliance, according to a press release, that combines the technologies of each company to deliver a new generation of medical functionality to wearable devices. The press release reports that the agreement encompasses the licensing of AliveCor technology and an [...]
MagicTouch AVF Concept Medical has received the CE mark for its MagicTouch sirolimus-coated percutaneous transluminal angioplasty (PTA) catheter, making the catheter the first commercially available sirolimus device for peripheral arterial disease. The MagicTouch catheter has also been approved for treating erectile dysfunction (MagicTouch ED) and for managing arteriovenous fistula complications (MagicTouch AVF). [...]
Michael Jaff Boston Scientific recently announced that vascular medicine specialist Michael R Jaff (Newton-Wellesley Hospital, Newton, USA) will be joining the company as vice president, clinical affairs, innovation and technology, peripheral interventions. His role will involve, according to Boston Scientific, leading clinical and medical affairs strategies to support the development and commercialisation [...]
CorPath GRX As of 29 October 2019, Siemens Healthineers now owns Corindus Vascular Robotics—developer of a robot-assisted system (CorPath) for interventional coronary and vascular procedures. A press release reports that, prior to the closing of the acquisition, 87.5% of Corindus’ stakeholders approved the purchase. It adds that the company is now part [...]
The FDA has issued a new safety communication about Type III endoleaks with AFX endovascular grafts (Endologix). According to the safety communication, there may be a higher risk of Type III endoleaks with the use of AFX with Duraply and with AFX2. The FDA reports that this communication is based on a review of [...]
CE mark—TrelliX embolic coil system (Shape Memory Medical) Shape Memory Medical has received the CE mark for its TrelliX embolic coil system. A press release reports that the TrelliX embolic coil system is intended to obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The CE-marked indications include: intracranial [...]
CorFlow Therapeutics has been granted Breakthrough Device designation from the FDA for its CorFlow Controlled Flow Infusion (CoFITM) system. According to a press release, the device is included in the Breakthrough Designation programme with the indication for use statement: “The CoFITM System is indicated for diagnostic assessment of the coronary microcirculation immediately following PCI (“stenting”), [...]
Venarum Medical is in receipt of a mentorship grant in further support of its awarded Phase II SBIR Grant “EVVS: EndoVenous Valve System” currently underway. Under its Phase II work, Venarum proposes to verify the preclinical safety of the endovenous valve system (EVVS). A press release reports that the valve system is a novel [...]
Viz.ai, who is developing the first synchronised healthcare software (Viz) using artificial intelligence (AI), has announced a $50 million Series B funding. A press release reports that the funding round was led by Greenoaks with participation from Threshold Ventures, CRV along with existing investors GV and Kleiner Perkins. The press release adds that Viz.ai [...]
Restore (Cardionovum), a paclitaxel-coated coronary balloon, now has Chinese market approval for in-stent restenosis and small vessel disease. The approval was given based on the results from two clinical studies in Chinese populations: RESTORE ISR CHINA and RESTORE SVD CHINA. RESTORE ISR CHINA and RESTORE SVD CHINA were both multicentre, randomised controlled trials. RESTORE [...]
Infuse The US Food and Drug Administration (FDA) has approved a new prospective, randomised clinical trial evaluating the use of recombinant human bone morphogenetic protein-2 (rhBMP-2, Infuse, Medtronic) during transforaminal lumbar interbody fusion (TLIF) procedures. The study is part of Medtronic’s long-term global clinical trial programme (BONE) evaluating the safety and efficacy [...]
GTX medical BV (GTX) and NeuroRecovery Technologies have announced they have merged to create a company committed to developing novel neuromodulation therapies to improve functional recovery of people with spinal cord injuries; the merged entity will be known as GTX medical BV. Furthermore, the Christopher & Dana Reeve Foundation—a non-profit organisation dedicated to advancing [...]
Perflow Medical has received CE mark approval for the Cascade Agile non-occlusive remodelling net (Cascade Agile). Expanding the Cascade product family, a press release reports, the Cascade Agile optimises control for distal and tortuous vessel anatomy during coil embolisation of intracranial aneurysms. The Cascade Agile is the latest addition to Perflow’s portfolio of novel [...]
TrelliX Shape Memory Medical has received the CE mark for its TrelliX embolic coil system. A press release reports that the TrelliX embolic coil system is intended to obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The CE-marked indications include: intracranial aneurysms, other neurovascular abnormalities such [...]
MagicTouch AVF Concept Medical BV has received the CE mark for its range of MagicTouch drug-coated balloons. The balloons are indicated for peripheral arterial disease, erectile dysfunction, arteriovenous fistula and arteriovenous graft. The CE mark approvals mean that the MagicTouch percutaneous transluminal angioplasty (PTA) catheter is the only commercially available, CE-mark certified, [...]
Canon Medical has received 510(k) clearance on its advanced intelligent Clear-IQ engine (AiCE) for the Aquilion Precision, which further expands access to its new deep convolutional neural network (DCNN) image reconstruction technology. This technology, now available on both the Aquilion Precision and Aquilion ONE/GENESIS Edition premium computed tomography (CT) systems, uses a deep learning [...]
A press release reports that the Michael C Greiner, executive vice president and chief financial officer (CFO), of AngioDynamics will be departing the company. It adds that Stephen A Trowbridge—senior vice president and general counsel—will assume the role of interim Chief Financial Officer in addition to his current responsibilities. Greiner will remain with AngioDynamics [...]
Source: BIBA MedTech Aortic Segmentation Monitor The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Medtronic for its novel Valiant thoracoabdominal aneurysm (TAAA) stent graft. A press release reports that the device is designed to offer an off-the-shelf solution for complex endovascular aneurysm repair (EVAR) procedures, adding that [...]
Tom Oxley Synchron recently announced the first successful implant of its minimally-invasive neural interface technology (Stentrode) as part of a trial evaluating the safety and efficacy of the technology for restoring communication in people with severe paralysis. The technology uses modular training software (BrainOs) to control assistive technologies through thought. The company’s [...]
FDA 510 (k) clearance—FluoroShield (Omega Medical) Omega Medical Imaging, manufactures of Artificial Intelligence Fluoroscopy/Cine (AIF/C) Imaging systems, has received FDA 510 (k) clearance for its FluoroShield with their 2020 Cardiac Flat Panel Detector. A press release reports that the FluoroShield system allows for auto collimation during interventional fluoro or cine cases while maintaining a [...]
The medical technology Bentley company has been named FOCUS Growth Champion 2020. A press release reports that—together with Statista, one of the world’s biggest online statistics platforms—the magazine FOCUS searched for the top 500 companies to have achieved a high percentage of sales growth between 2015 and 2018. Only companies with their headquarters in [...]
Mike McNulty Miach Orthopaedics has announced that Michael J McNulty has joined the company as vice president of sales and marketing. According to a press release, McNulty will lead Miach’s commercialisation and sales efforts for the Bridge-Enhanced ACL Repair (BEAR) Implant—an investigational device designed for anterior cruciate ligament repair. McNulty brings more [...]
Omega Medical Imaging, manufactures of Artificial Intelligence Fluoroscopy/Cine (AIF/C) Imaging systems, has received FDA 510 (k) clearance for its FluoroShield with their 2020 Cardiac Flat Panel Detector. A press release reports that the FluoroShield system allows for auto collimation during interventional fluoro or cine cases while maintaining a perspective of surrounding anatomy. The blended [...]
Stellarex 0.035 Philips has added two new balloons to its portfolio of Stellarex 0.035 low-dose drug-coated balloons, following approval from the FDA. The new 200mm and 150mm Stellarex 0.035 low-dose balloons are now approved and available, in the USA, for the treatment of de novo and restenotic lesions in native superficial femoral [...]
Sern Lim Heart Research UK has awarded the Novel and Emerging Technologies (NET) grant—of almost £150,000—to Sern Lim (Queen Elizabeth Hospital, Birmingham, UK) and colleagues for a project that is evaluating the use of wave intensity analysis (WIA) to diagnose heart failure and assess patients who may benefit from left ventricular assist [...]
Titan Medical is withdrawing all forecasts with respect to the cost and timing of the development of its robotic surgical system beyond the fourth quarter of 2019 because its lack of financing has caused its primary product development supplier to limit the development work on its robotic surgical system. This supplier has also terminated [...]
AliveCor receiving their award UC San Francisco’s Health Hub—an innovation hub and startup studio supporting the next wave of digital health entrepreneurs—has announced the winners of its Digital Health Awards. A press release reports that this awards event celebrates the achievements of innovative companies dramatically improving healthcare with technology. The winners were [...]
Pilot TLS Vygon has acquired the Italian firm Pilot, which specialises in ECG guidance devices. The aim of this transaction, according to a press release, is to acquire the ECG location and navigation technology of the Pilot TLS product (already marketed by Vygon). The press release states that Pilot TLS is one [...]
Michael Jaff Michael R Jaff is to be vice president, clinical affairs, innovation and technology, peripheral interventions of Boston Scientific by January 2020. In this role, a press release reports, Jaff will lead clinical and medical affairs strategies to support the development and commercialisation of the company’s peripheral vascular medical device portfolio, [...]
CardioCel Admedus has sold its CardioCel and VascuCel patch business to US-based LeMaitre Vascular for up to $A36.2M ($A22.8M upfront) in cash payments. A press release reports that these products originated from the Admedus’s proprietary, regenerative bioscaffold platform technology and are used to address multiple cardiovascular procedures and repairs. The company’s CEO, [...]
Helix BioCardia has announced the renewal of the CE mark for its Helix biotherapeutic delivery catheter and Morph universal deflectable guide catheter—both are used in the delivery of biotherapeutics to the heart. A press release reports that the CE mark renewal enables BioCardia to continue supporting partners conducting biotherapeutic clinical trials outside [...]
IASD Corvia Medical has received FDA Breakthrough Device Designation for its Interatrial Shunt Device (IASD) for heart failure. A press release reports that the IASD is the world’s first transcatheter device for heart failure with preserved (HFpEF) and mid-range (HFmrEF) ejection fraction. It is designed to provide continuous and dynamic decompression of [...]
The FDA has approved a device (geko, Sky Medical Technology) for stimulation of the calf muscles to prevent venous thrombosis in non-surgical patients at risk for venous thromboembolism. A press release reports that this adds to Sky’s established 510k clearance for immediate post-surgical stimulation of calf muscles to prevent venous thromboembolism, increasing blood circulation [...]
Guerbet has signed an exclusive agreement with icometrix for the distribution in France, Italy and Brazil of icobrain, their Saas (software as a service) artificial intelligence (AI) based medical imaging solution. According to a press release, icobrain is designed to help radiologists and neurologists diagnose and monitor patients with neurological disorders. The AI software [...]
CLEAR system Insera Therapeutics has announced that the first two ischaemic stroke patients have been treated with its cyclic aspiration system CLEAR. The company received the CE mark for the system in March 2019. The CLEAR aspiration system is a digital vacuum aspiration system that allows operators to employ uniform suction or [...]
CAT RX Penumbra has announced the enrolment of the first patient in its CHEETAH study, a prospective, multicentre US study to evaluate the safety and performance of the Indigo system with CAT RX aspiration catheter in the coronary vessels. Introduced in 2018, as part of the Indigo aspiration system, the Indigo CAT [...]
Torus stent graft PQ Bypass has received full approval of its investigational device exemption (IDE) trial (TORUS 2) of its Torus stent graft, which is a novel stent graft platform designed for the treatment of peripheral arterial disease in the superficial femoral artery. By acquiring early FDA feedback through the presubmission process, [...]
Medtronic is recalling its 6Fr Sherpa NX Active Guide Catheter because of a risk of the outer material separating from the device resulting in detached fragments, which could result in the underlying stainless-steel braid wires being exposed. The FDA, in a statement, has deemed this to be a “Class I recall”. According to the [...]
Cordella system Endotronix has announced the expansion of its Series D financing round, bringing the total for the round to $70 million. The expansion syndicate for the LSP-led round includes new investment from an additional unnamed medical device strategic investor as well as participation from existing investors, including Aperture Venture Partners, BioVentures [...]
ControlRad has completed $15 million in financing and has added Ryan Drant and Tim Patrick have to its board of directors. The Series B round, which was led by Questa Capital, will be used for fuelling the commercial launch of the innovative ControlRad Trace system. A press release reports that ControlRad Trace is the [...]
Cardioform ASD Occluder The Gore Cardioform ASD Occluder has received the CE mark. A press release reports that the device offers physicians a clinically proven design in a device that, in a recent study, met its primary endpoint for the percutaneous, transcatheter closure of ostium secundum atrial defects (ASDs). It adds that [...]
Avance BioCardia has announced the US commercial availability of its Avance bi-directional steerable introducer sheath for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum. The product became available in late September. A press release reports that the Avance device addresses the [...]
Source: BIBA MedTech Aortic Segmentation Monitor Aortic Insights is a quarterly report that provides in-depth analysis of the key findings of the Aortic Segmentation Monitor (BIBA MedTech Insights). Each quarter, the monitor tracks aortic procedures performed in Western Europe. It looks at the segment treated (infrarenal, complex, and thoracic), type of procedure [...]
EV ICD Medtronic has commenced a worldwide pivotal study to evaluate an investigational extravascular implantable cardioverter defibrillator (EV ICD) system for the management of tachycardia. A press release reports that the system is designed to provided defibrillation, as with a traditional ICD, but has a lead outside of the heart and veins. [...]
Intersim Medtronic has filed a pre-market approval (PMA) supplement with the FDA for approval of its InterStim Micro neurostimulator and also its InterStim SureScan MRI leads. InterStim Micro is a rechargeable, implantable sacral neuromodulation device designed to treat patients affected by overactive bladder, urinary urge incontinence, unobstructed urinary retention and faecal incontinence. The [...]
TriClip New data indicate that a novel transcatheter system for tricuspid valve repair (TriClip, Abbott) was safe and associated with strong clinical improvement at six-months—including a reduction in tricuspid regurgitation and improvement in quality of life—in patients with severe tricuspid regurgitation. The findings were presented at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) [...]
Jeffrey B Jump In a move to improve the safety of medical devices, in May 2017, the European Union (EU) announced a series of new Medical Device Regulations (MDR) and these are due to come into full force in May next year (2020). These new regulations will not only affect new products [...]
FDA approval—Proclaim XR (Abbott) Abbott has received FDA approval for its Proclaim XR recharge-free neurostimulation system for people with chronic pain. A press release reports that the Proclaim XR platform offers a low dose of Abbott’s proprietary BurstDR stimulation waveform, which has been designed to mimic natural patterns found in the brain. A press [...]
According to a study published in The Lancet Digital Health, artificial intelligence (AI) may be as effective as health professionals at diagnosing disease. The study represents the first systematic review and meta-analysis of the role of AI for diagnosing medical conditions. A press release reports that the small number of high quality studies of [...]
Abiomed’s Impella 5.5 with SmartAssist has received US FDA pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days. The Impella 5.5 with SmartAssist system is a temporary ventricular support device intended for short term (14 days) use and indicated for the treatment of ongoing cardiogenic [...]
Proclaim XTR Abbott has received FDA approval for its Proclaim XR recharge-free neurostimulation system for people with chronic pain. A press release reports that the Proclaim XR platform offers a low dose of Abbott’s proprietary BurstDR stimulation waveform, which has been designed to mimic natural patterns found in the brain. The press [...]
The FDA has cleared three modules of AI-Rad Companion Chest CT, a software assistant from Siemens Healthineers that is designed to bring artificial intelligence (AI) to computed tomography (CT). Representing the first intelligent assistant of the new AI-Rad Companion platform, AI-Rad Companion Chest CT helps radiologists interpret images of the thorax quickly with desired [...]
Intrepid Medtronic has received FDA approval to begin an early feasibility study for its Intrepid transcatheter mitral valve implantation (TMVI) system using a minimally-invasive transfemoral access approach. A press release reports that this announcement builds upon primary endpoint outcomes of the Intrepid TMVI clinical trial (APOLLO), which showed that TMVI (via the [...]
MedTech Innovator has announced Forest Devices as the winner of its 2019 Global Competition. The winning company was determined by a live audience vote on 24 September at The MedTech Conference (23–25 September, Boston, USA), which is supported by AdvaMed. Forest Devices is developing a portable device that uses EEG monitoring and machine learning [...]
Misonix has completed its previously announced acquisition of privately held Solsys Medical in an all-stock transaction valued at approximately $109 million on the date prior to closing. A press release reports that Solsys and its leading cellular and tissue-based wound treatment, TheraSkin, is highly complementary to Misonix’s cutting-edge ultrasonic wound debridement solution, SonicOne—providing Misonix with a large direct advanced wound [...]
According to a study presented at 2019 American Society for Radiation Oncology (ASTRO) annual meeting (15–18 September, Chicago, USA), treating high-risk heart patients with a single, high dose of radiation therapy could substantially reduce episodes of rapid, abnormal heartbeats for more than two years. In collaboration with Phillip Cuculich (Washington University School of Medicine, [...]
K Sivaprasad (Govt TD Medical College, Alappuzha, India) reported at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25–29 September, San Francisco, USA) yesterday that the Evermine 50 stent (Meril Life), which has a strut thickness of 50μm, is associated with a low rate of major adverse events (MACE) at 12 months. Previous studies have [...]
Source: CRF This morning at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25–29 September, San Francisco, USA), InterVene won the TCT-Shark Tank Innovation Competition for its novel endovenous system (BlueLeaf) for forming valves in patients with deep vein reflux and/or chronic venous insufficiency. The award, which is supported by the Jon DeHaan [...]
AccuCinch Today at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25–29 September, San Francisco, USA), data from an interim analysis of heart failure patients treated in the CorCinch FMR study were presented. These data show, a press release reports, that the AccuCinch ventricular repair system (Ancora Heart) is associated with a favourable safety [...]
A press release reports that Terumo BCT’s new $100,000 Therapeutic Plasma Exchange (TPE) Innovation Award will help clinical investigators expand the field of data for certain types of autoimmune conditions, known as IgG4-mediated diseases. It adds that TPE is as an established therapy for many diseases, but the understanding of how it works is [...]
MedAlliance has been awarded FDA Breakthrough Device Designation for the Selution SLR, which is a sustained limus release drug-eluting balloon catheter for the treatment of below-the-knee disease. According to a press release, the company was the first drug-eluting balloon company in the world to receive FDA Breakthrough Device Designation status for the treatment of [...]
Eko has secured $20 million in Series B funding. Led by ARTIS Ventures, according to a press release, the funding will drive further research and development and commercialisation of Eko’s machine learning platform for cardiac screening and analysis. Additional new and returning investors in the round include DigiTx Partners, NTT Venture Capital (NTTVC), 3M [...]
Cardiovascular Systems (CSI) has announced FDA PMA approval of its ViperWire Advance coronary guidewire with Flex Tip (ViperWire Advance with Flex Tip). A press release reports that the ViperWire Advance with Flex Tip is the latest advancement to CSI’s coronary Diamondback 360 orbital atherectomy system. It adds that the new guidewire offers a combination [...]
R-One Robocath has announced the success of its first two coronary angioplasties performed with assistance from its R-One robotic platform. The procedures were performed in France at Rouen University Hospital by Eric Durand and Rémi Sabatier, and at Clinique Pasteur in Toulouse by Jean Fajadet. According to a press release, R-One assists [...]
During a session on radiation protection technologies at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25–29 September, San Francisco, USA), Lloyd W Klein (Rush Medical College, Chicago, USA) said that Henry V led the heavily outnumbered English army to victory at the Battle of Agincourt (1415) because he “figured out how to use an [...]
Jeffrey B Jump, chairman and CEO of MedAlliance, has announced on LinkedIn that Laurent Granier has been appointed as VP Cardiovascular, responsible for the Cardiovascular commercial activities of MedAlliance. In his post on LinkedIn, Jump states that Granier has more than 25 years of experience in the Medical Device industry and more specifically in Cardiovascular, [...]
Evolut PRO+ The FDA has approved the Evolut PRO+ transcatheter aortic valve implantation (TAVI) system, which a press release states builds off the proven self-expanding, supra-annular Evolut TAVI platform. The press release adds that the Evolut PRO+ includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for [...]
MedTech Innovator, a non-profit start-up accelerator in the medical technology industry, has announced the five companies—Flosonics Medical, Forest Devices, Koya, OncoRes Medical, and Venari Medical—that have been selected as finalists to compete for the title of “MedTech Innovator 2019”. A press release reports that these finalists were chosen from more than 800 applicants, and [...]
CE mark— Masters HP 15mm and Amplatzer Piccolo Occluder (both Abbott) Two of Abbott’s paediatric devices—Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder—have received European approval (CE mark). A press release reports that the devices, available in the USA, offer young paediatric patients and their families “hope when no other [...]
Wallaby Medical has announced CE mark approval and FDA 510(k) clearance of its differentiated embolic coil system—the Avenir coil system. The intended use for the Avenir coil system is for endovascular embolisation of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Avenir coil system is also intended for [...]
Viz.ai has been recognised in the inaugural Forbes AI list as one of the USA’s 50 most promising artificial intelligence (AI) companies. The company uses AI to synchronize stroke care, with the aim of reducing time to treatment and expanding patient access to life-saving care. The Forbes AI list highlights the most promising private [...]
SS02 Several companies, including Boston Scientific and Corindus Vascular Robotics, have released details of their presentations at the upcoming 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25–29 September, San Francisco, USA). Ancora Heart 25 September (Wednesday); 4.35pm; Room 203 Abstract: Hypertension and heart failure therapies (session II) heart failure therapies, TCT 88—six-month outcomes [...]
STAR Mapping RHYTHM AI has announced the closure of a £2.15 million seed financing round. The round was led by an affiliate of Rinkelberg Capital, a private wealth management firm based in London, and was supported by investment from founders. The proceeds will fund a multicentre study of STAR Mapping to improve [...]
pDVA LimFlow has received FDA approval for its investigational device exemption (IDE) for the PROMISE II pivotal study of the LimFlow percutaneous deep vein arterialisation (pDVA) system. PROMISE II is a multicentre, prospective, single-arm study to be conducted in the USA and Japan. Using an adaptive statistical design, the study plans to [...]
Kaia Health US team Kaia Health, a digital therapeutics company, has announced an $8 million funding round; a press release reports that this is the second significant investment this year. The infusion of capital is led by Optum Ventures. According to the press release, Kaia Health has developed a smartphone-based approach for [...]
Tria heart valve Foldax announced its first-in-human use of the Tria heart valve under its FDA early feasibility study for the treatment of aortic valve disease. Clinicians at Beaumont Hospital, Royal Oak, in Michigan, implanted this innovative flexible polymer heart valve, which has been designed to address durability and thrombogenicity issues of [...]
Jeff Shuren The FDA has issued draft guidance titled “safer technologies programme for medical devices”, which is a voluntary programme that—a press release reports—is expected to significantly improve the safety of available treatments or diagnostic devices for diseases or conditions that are less serious than those eligible for the agency’s Breakthrough Devices [...]
EBR Systems has announced that the FDA has granted Breakthrough Device Designation for its WiSE cardiac resynchronisation therapy (CRT) for the treatment of heart failure. The WiSE (wireless stimulation endocardially) CRT system is designed to improve the heart’s pumping ability by synchronising the left and right ventricles to distribute blood to the lungs and [...]
CroíValve has secured €4 million in additional financing, which includes €2.5 million from the European Union (EU) under their Horizon 2020 SME Instrument grant and €1.5 million from Broadview Ventures and current investors (HBAN MedTech and Irrus Syndicates, Atlantic Bridge University Fund and SOSV Ventures). The funding will accelerate the development of the company’s [...]
Biotronik has become the world’s first manufacturer to receive European Medical Device Regulation (MDR) certification for a Class III (highest risk) medical device. Following a successful conformity assessment, the company also obtained MDR certification for its quality management system. Class III medical devices represent the highest risk class of medical devices according to the [...]
Active Implants has announced that the NUsurface Meniscus implant has been granted a Breakthrough Device Designation from the FDA. A press release reports that the NUsurface Meniscus implant is the first “artificial meniscus” to be marketed in Europe and, if cleared by the FDA, would be the first artificial meniscus in the USA. The [...]
Piccolo Occluder Two of Abbott’s paediatric devices—Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder—have received European approval (CE mark). A press release reports that the devices, available in the USA, offer young paediatric patients and their families “hope when no other suitable treatment option may exist”. The press [...]
Dapagliflozin (Farixga) The FDA has granted Fast Track designation for the development of dapagliflozin (Farixga, AstraZeneca) to reduce the risk of cardiovascular death or the worsening of heart failure in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF). The FDA’s Fast Track programme is designed to [...]
Torpedo Merit Medical has launched Torpedo—a proprietary gelatin foam indicated for use in the embolisation of hypervascular tumours—onto the market. According to a press release, the Torpedo provides physicians with a pre-shaped gelatin foam loaded into a cartridge with an optional blunt stylet, removing the need for manual foam shaping and providing [...]
The IN.PACT AV access clinical study, which is evaluating the investigational IN.PACT AV drug-coated balloon for the management of patients with de novo or non-stented restenotic arteriovenous (AV) fistulae lesions, has met its primary safety and effectiveness endpoints. Data from the trial were presented today at the Cardiovascular and Interventional Radiology Society of Europe [...]
Stereotaxis has appointed Kimberly Peery as chief financial officer, effective 1 October 2019. Martin Stammer, who has served as chief financial officer (CFO) since 2013, has accepted a position as the CFO of a large professional services firm headquartered in the St Louis area (USA) and will resign from the Stereotaxis, effective 30 September [...]
Virtue AVF Orchestra BioMed, in partnership with Terumo, has secured Breakthrough Device Designation by the FDA for its Virtue sirolimus-eluting balloon (SEB) in the treatment of below-the-knee peripheral arterial disease. A press release reports that currently approved therapeutic options for peripheral arterial disease are limited and have been shown to be marginally [...]
FDA approval—r-SNM system (Axonics) Axonics Modulation Technologies has announced the FDA approval of the Axonics r-SNM system. A press release reports that the Axonics system is the first rechargeable SNM system approved for sale in the USA, Europe, Canada and Australia. It is now approved, in the USA, for the management of faecal incontinence. [...]
ACR (Healthy.io) Healthy.io has received 510(k) clearance from the FDA for its smartphone-based ACR test to be used in the aid of diagnosing chronic kidney disease. A press release reports that this is the second FDA clearance the company has received. Additionally, the company also closed a $60 million Series C funding [...]
CroíValve has secured €4 million in additional financing, which includes €2.5 million from the European Union (EU) under their Horizon 2020 SME Instrument grant and €1.5 million from Broadview Ventures and current investors (HBAN MedTech and Irrus Syndicates, Atlantic Bridge University Fund and SOSV Ventures). The funding will accelerate the development of the company’s [...]
VentriGel The results of a FDA-approved Phase 1 clinical trial indicate that a hydrogel (VentriGel, Ventrix) can be safely injected via catheter into patients who had a myocardial infarction in the past two to 36 months. The trial is the first to test a hydrogel designed to repair cardiac tissue, and it [...]
ARTIS Icono biplane The FDA has cleared the ARTIS icono (Siemens Healtineers)—a high-precision family of angiography systems that are designed to permit a wide range of minimally invasive procedures to be performed in a single interventional suite. The ARTIS icono biplane system is engineered for optimal use in neuroradiology and abdominal imaging, [...]
Carsten Tschöpe At the 2019 European Society of Cardiology (ESC) Congress (31 August–4 September, Paris, France), Carsten Tschöpe (Charité Hospital, Berlin, Germany) outlined the use of the “Propella” approach in myocarditis patients with cardiogenic shock. He explained that the approach involves the prolonged use of an Impella heart pump (Abiomed) to provide [...]
LARIAT AtriCure has entered into a definitive agreement to acquire SentreHEART, which developed the LARIAT device for left atrial appendage closure in patients with atrial fibrillation. A press release reports that the transaction consideration consists of an upfront payment of approximately US$40 million in cash and AtriCure common stock, plus additional contingent [...]
V-Wave has announced that the FDA has granted it a second Breakthrough Device Designation—the first was for its interatrial shunt for heart failure and the second is for pulmonary arterial hypertension. The company is testing a minimally invasive, implanted interatrial shunt device for pulmonary artery hypertension in a global approved investigational device exemption (IDE) [...]
Checkpoint BEST Checkpoint Surgical has received FDA Breakthrough Device Designation for the Checkpoint brief electrostimulation therapy (BEST) system. The Checkpoint BEST system is, a press release reports, designed to provide electrical stimulation of peripheral nerves to promote nerve regeneration as an adjunct to surgical intervention following nerve injury, with the goal of [...]
Critical Care Suite GE Healthcare has received FDA 510(k) clearance of its Critical Care Suite, which a press release reports are an industry-first collection of artificial intelligence (AI) algorithms embedded on a mobile X-ray device. Built in collaboration with UC San Francisco (UCSF), using GE Healthcare’s Edison platform, the AI algorithms are [...]
r-SNM Axonics Modulation Technologies has announced the FDA approval of the Axonics r-SNM system. A press release reports that the Axonics system is the first rechargeable SNM system approved for sale in the USA, Europe, Canada and Australia. It is now approved, in the USA, for the management of faecal incontinence. The [...]
Source: BIBA MedTech TAVI Monitor A new study indicates that the Meridian transcatheter aortic valve implantation (TAVI) valve (HLT) is associated with a 30-day mortality rate of 8% and a six-month mortality rate of 12%. The valve is fully retrievable after deployment, which allows an accurate assessment of valve positioning and performance [...]
Atman Shah Virtual patient care is creating exciting learning opportunities for interventional cardiologists. Atman P. Shah considers how training through gaming can deliver a state-of-the-art profession. Recently, I was between patients, with a few minutes to spare. I opened an app on my phone designed for practising cardiology cases and began to [...]
Abbott has announced its TRILUMINATE Pivotal trial to evaluate the safety and effectiveness of the TriClip transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation. This is the first pivotal Investigational Device Exemption (IDE) trial in the USA to evaluate a catheter-based, non-surgical treatment for patients with severe tricuspid regurgitation. The [...]
Jeffrey Shuren The FDA issued a final guidance, Humanitarian Device Exemption (HDE) programme, with the aim of providing provide updated information about the HDE application process and other considerations specific to the programme. An HDE application is the premarket submission for a Humanitarian Use Device (HUD), which is a medical device intended [...]
Zio XT iRhythm Technologies has announced a collaboration with Verily; a press release reports that this collaboration aims to bring together iRhythm’s expertise in artificial intelligence (AI) based arrhythmia diagnosis and Verily’s advanced health data analytics technologies to address the millions of patients living with undiagnosed atrial fibrillation. Under the terms of [...]
Wideblue, a product design and development consultancy, has won a gold award in the European Product Design Awards for a medical device that it developed for Cambridge Respiratory Innovation Ltd. The device, N-Tidal, is a small battery powered personal capnometer—used to measure the amount of CO2 in exhaled breath. Russell Overend, managing director of [...]
Life Image has announced the launch of its new Real World Imaging (RWI) offering, with the aim of responding to researcher needs for maturing insights and accelerating drug development decisions. With its digital platform that is powered by industry-leading interoperability standards, according to a press release, Life Image specialises in “living” or evolving datasets [...]
CE mark approval—Moderato implantable pulse generator system (Orchestra BioMed) Orchestra BioMed has received CE mark approval for its Moderato implantable pulse generator system that is designed to deliver BackBeat Cardiac Neuromodulation Therapy for the treatment of hypertension while also providing standard pacemaker functions. Additionally, the Cardiovascular Research Foundation (CRF) has selected the MODERATO II [...]
Bardy Diagnostics has received 510(k) clearance from the FDA for a 14-day version of the Carnation Ambulatory Monitor (CAM), which a press release says is market’s only P-wave centric ambulatory cardiac patch monitor and arrhythmia detection device. Developed to provide clinicians greater flexibility in cardiac monitoring over a longer period, the CAM patch will [...]
BackBeat CNT Orchestra BioMed has received CE mark approval for its Moderato implantable pulse generator system that is designed to deliver BackBeat Cardiac Neuromodulation Therapy for the treatment of hypertension while also providing standard pacemaker functions. Additionally, the Cardiovascular Research Foundation (CRF) has selected the MODERATO II clinical study, which evaluated BackBeat [...]
V-Lap A clinical trial, being conducted at the Queen Elizabeth Hospital (Birmingham, UK), of the world’s first wireless in-heart microcomputer has begun. A press release reports that researchers hope that the ground-breaking technology will dramatically improve the quality of life for people living with heart failure, helping them better manage the condition [...]
Shockwave Lithotripsy Shockwave Medical has received Breakthrough Device Designation from FDA for its Shockwave intravascular lithotripsy (IVL) system with the Shockwave C2 coronary IVL catheter, which is currently the subject of an Investigational Device Exemption (IDE) study called DISRUPT CAD III. A press release reports that the Shockwave C2 IVL catheter is [...]
Stryker has announced a definitive agreement to acquire Mobius Imaging and its sister company, GYS Tech (DBA Cardan Robotics) in an all cash transaction of approximately $370 million upfront and up to $130 million of contingent payments associated with development and commercial milestones. The acquisition, a press release reports, provides Stryker’s Spine division with [...]
Andrew Mullen Medical device company Creavo Medical Technologies has appointed its operations director Andrew Mullen to its Board of Directors, which will see him lead on research and development (R&D) and regulatory affairs. A press release reports that Mullen has held the operator directors at Creavo for over a year, where he [...]
Lucien Goffart Robocath, which is developing and commercialising cardiovascular robotic systems (such as R-One) for the treatment of vascular diseases, has raised €5 million ($5.5M) to support the roll out of its robotic platform in strategic European target markets. It has also hired Lucien Goffart as CEO. The €5 million ($5.5M) capital [...]
At the 2019 European Society Cardiology (ESC) congress (31 August – 4 September, Paris, France), Abiomed revealed that its Impella CP with SmartAssist technology is now commercially available in Europe. A press release reports that the system is designed to improve patient outcomes with advanced algorithms and simplified patient management. It adds that the [...]
MagicTouch AVF Concept Medical has been granted Breakthrough Device Designation from the FDA for the MagicTouch AVF, sirolimus-coated, balloon catheter for the management of stenotic lesions of arteriovenous fistulae or arteriovenous graft in haemodialysis treatment of renal failure. The proposed indications for the MagicTouch AVF devices are for it to be used, [...]
Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe and the USA. It also covers recalls, safety notices, and indication withdrawals. This report covers from Monday 26 August to Friday 30 August. FDA approval—MID-C (ApiFix) ApiFix has received FDA approval, via a Humanitarian Device Exemption (HDE), to market the [...]
Omar Ishrak Omar Ishrak, Medtronic’s chairman and CEO is to retire on 26 April 2020, following the end of the company’s current fiscal year. Also, the Medtronic Board of Directors has announced key leadership appointments as part of its multi-year, leadership succession planning process. A press release reports that these announcements will [...]
Scientists from the Warwick Manufacturing Group (University of Warwick, Warwick, UK) have developed a new 3D MRI computing technique that involves a numerically stable technique of left ventricle myocardial tracking, a 3D extension of local weighted mean function to transform MRI pixels, and a 3D extension of Hierarchical Template Matching model for myocardial tracking [...]
Biobeat’s smartwatch and patch. The FDA has granted a 510K clearance for Biobeat’s patch and watch for measurement of blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home. According to press release, Biobeat’s products enable cloud-based healthcare with connectivity either through a smartphone or a dedicated gateway. [...]
ApiFix has received FDA approval, via a Humanitarian Device Exemption (HDE), to market the minimally invasive deformity correction system for the treatment of progressive adolescent idiopathic scoliosis. A press release reports that ApiFix’s MID-C technology is a posterior dynamic deformity correction system that enables surgeons to perform a unique treatment providing permanent curve correction [...]
A new study, by Tom Nadarzynski (University of Westminster, London, UK) and others, indicates that that a large proportion of the general public are reluctant to use artificial intelligence (AI) led services for their healthcare, particularly for more serious illnesses. The results of the study come after the UK Government announced £250 million funding [...]
Mission Control AdventHealth has opened its new “Mission Control”, which a press release describes as the largest command centre of its kind. Its aim to make clinical operations across the healthcare system as streamlined and efficient as possible. The press release adds that the Mission Control will function like its NASA namesake, [...]
Heart Failure Interview at ESC - Meeting directions Please be at the meeting location in front of the entrance to Hall #3 10 minutes before your interview is due to start. I will be there waiting for you, from here it's a short 5 minute walk to the interview location. If you have any [...]
Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe and the USA. It also covers recalls, safety notices, and indication withdrawals. This report covers from Monday 19 August to Friday 23 August. FDA Class I recall—delivery system of Sapien 3 Ultra The FDA has issued a Class I recall—which [...]
Alphatec (ATEC) has announced today that the Delaware Chancery Court entered summary judgment in favour of its chairman and CEO, Pat Miles—terminating all non-competition and employee non-solicitation claims brought against Miles and Atec by NuVasive. According to a press release, Miles joined ATEC as its executive chairman on 2 October 2017, and assumed the [...]
DiscGenics has announced that the FDA has granted Fast Track designation for its investigational cell therapy, IDCT, currently being evaluated in regulator-allowed clinical trials in the USA and Japan for the reduction in pain and disability associated with degenerative disc disease. A press release reports that IDCT is reproducibly manufactured in a cGMP environment [...]
Miracor Medical has been granted Breakthrough Device Designation by the FDA for its PiCSO Impulse System for treatment of ST-segment elevation myocardial infarction (STEMI) patients. The PiCSO impulse system is designed to clear the coronary microcirculation by intermittently occluding the coronary sinus outflow resulting in improved perfusion of the infarcted area of the heart. [...]
Varian has completed its asset purchase of the Boston Scientific portfolio of drug-loadable microsphere and bland embolic bead products for treating arteriovenous malformations and hypervascular tumours. According to a press release, this acquisition expands the portfolio of Varian interventional oncology solutions. Back in July, Varian revealed it had signed an asset purchase agreement to [...]
The FDA has issued a Class I recall—which it describes as “the most serious type of recall”—for the delivery system of the Sapien 3 Ultra transcatheter aortic valve implantation (TAVI) system. The recall follows Edwards Lifesciences receiving reports of burst balloons during implantation procedures, and it comes just under a week after the FDA [...]
Each week, BIBA Briefings summarises the key market approvals of medical devices in Europe and the USA. It also covers recalls, safety notices, and indication withdrawals. This report covers from Monday 12 August to Friday 16 August. Cardiology FDA approval—Evolut R, Evolut PRO (Medtronic); Sapien 3, Sapien 3 Ultra (Edwards Lifesciences) The FDA has [...]
The FDA has approved the Barostim Neo system (CVRx) for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronisation therapy. A press release reports that, previously, the FDA gave the device a Breakthrough Device designation because it treats [...]
AMDS delivery system Ascyrus Medical has received Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) to treat acute Type A aortic dissections. A press release reports that this designation serves as validation of the clinical importance of the AMDS and represents a significant milestone in the continued [...]
V-Wave has announced that the FDA has just granted the company a Breakthrough Device Designation for its interatrial shunt for heart failure. V-Wave’s minimally invasive, implanted interatrial shunt is being evaluated in a global, randomised, controlled, double-blinded, 500 patient pivotal IDE trial called RELIEVE-HF. The study is enrolling advanced heart failure patients with preserved [...]
The Tether Zimmer Biomet has announced FDA approval for The Tether for treatment of scoliosis, providing a fusion-less alternative for young patients requiring surgery. A press release reports that The Tether uses a strong, flexible cord, rather than metal rods, to pull on the outside of a scoliosis curve to initially straighten [...]
Alphatec Holdings (ATEC) has announced the appointment of Eric Dasso as executive vice president, Adjunctive Technologies. The Company also announced the appointment of Wyatt Stanfield as Area Vice President, Sales, West, and Timothy Day as Territory Development Manager, Northeast, to further the development of ATEC’s strategic sales channel. Having successfully commercialised products and procedural [...]
Vercise Gevia Boston Scientific has announced the FDA approval of its ImageReady MRI labelling for the Vercise Gevia deep brain stimulation (DBS) system to be used in a full-body magnetic resonance imaging (MRI) environment. This system, with the Vercise Cartesia directional lead, is designed to treat the symptoms of Parkinson’s disease by [...]
Rick Nehm CardioMech has closed on a convertible note financing of $5 million, which it says was significantly oversubscribed. The note included investments from experienced MedTech investors and brings the total amount raised for CardioMech to $7.5 million in 2019. Proceeds from the raised funding will be used to further accelerate the [...]
Jon Serbousek Orthofix Medical has named Jon Serbousek as president of its Global Spine business (effective 5 August 2019). Serbousek is also to succeeds Brad Mason, the company’s retiring president and Chief Executive Officer (CEO), to be effective 1 November 2019. A seasoned executive with more than 30 years’ experience in the [...]
Source: BIBA MedTech Insights According to a BIBA MedTech survey, 52% of neurointerventionalists believe that they are the only specialists who have the relevant skills and experience to perform interventional stroke procedures (e.g. mechanical thrombectomy). However, of those who believe other specialities—with the appropriate training—could potentially perform such procedures, 58% propose interventional [...]
The FDA has approved Evolut R, Evolut PRO (Medtronic), Sapien 3 and Sapien 3 (Edwards Lifesciences) for the management of low-risk patients with severe aortic stenosis. The approval follows the publication—in the New England Journal of Medicine—of two studies that showed positive results with these devices in low-risk patients. Prior to the FDA approval, [...]
Concept Medical has been granted Breakthrough Device Designation from the FDA for its MagicTouch percutaneous transluminal angioplasty (PTA) device—a sirolimus drug-coated balloon catheter—for the treatment of below-the-knee lesions. Earlier this year, on 30 April 2019, Concept Medical received its first Breakthrough Device for its MagicTouch coronary balloon for the treatment of Coronary Artery Disease [...]
Endologix has received Investigational Device Exemption (IDE) approval from the FDA to commence a new pivotal study to evaluate the safety and effectiveness of the its chimney endovascular aneurysm sealing system (ChEVAS) for the endovascular treatment of complex abdominal aortic aneurysms. A press release reports that the ChEVAS system is an endovascular abdominal aortic [...]
AtriCure–developer of Isolator synergy ablation system for persistent atrial fibrillation—has entered into a definitive agreement to acquire SentreHEART, a privately held developer of percutaneous left atrial appendage (LAA) management solutions (including the LARIAT device). Under the terms of the agreement to acquire SentreHEART, the transaction consideration consists of an upfront payment of approximately $40 [...]
HealthTech Arkansas, a healthcare accelerator and investment fund that connects early-stage healthcare companies with disruptive technologies to Arkansas healthcare providers, has selected BardyDx to participate in its 2019 accelerator programme. BardyDx was chosen for its carnation ambulatory monitor (CAM)—the industry's only P-wave centric ambulatory cardiac patch monitor and arrhythmia detection device. HealthTech Arkansas is [...]
AccuCinch The first patient has been enrolled in the CorCinch EU study, which is a European multicentre clinical evaluation of the AccuCinch ventricular repair system (Ancora Heart) as a treatment for patients with reduced ejection fraction systolic heart failure. This is the second recently initiated study evaluating the AccuCinch system that specifically [...]
David West A private equity firm, Palatine (Manchester, UK), has announced that it has made a “significant investment” into a UK centre—Veincentre—that provides endovenous laser ablation (EVLA) for the management of varicose veins. The investment, according to Palatine, is the fourth to be made from the firm’s £100m “Impact Fund” that “targets [...]
Medtronic has completed its acquisition of Titan Spine, which has a range of interbody fusion devices that feature unique surface technology. A press release reports that the acquisition provides opportunities to bundle interbodies, screws, rods, biologics, and “enabling” technologies, such as navigation, to develop “integrated procedural solutions”. It adds that Titan Spine will now [...]
Source: BIBA MedTech Aortic Segmentation Monitor Endologix has announced that the CE mark for the Nellix endovascular aneurysm sealing (EVAS) system has been reinstated. The CE mark for the system was suspended on 22 January and now it that has been reinstated, Nellix will be made available for use at approved centres [...]
CorPath GRX Siemens Healthineers has entered into a merger agreement with US-based Corindus Vascular Robotics, which has a portfolio of robotic-assisted vascular interventions. Under the terms of the agreement, Siemens Healthineers will acquire all fully diluted shares of Corindus for US$4.28 per share in cash or US$1.1 billion in total. The transaction [...]
Procyrion has received Breakthrough Device designation by the US FDA for its Aortix system. According to a press release, Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalised for acute decompensated heart failure with worsening renal function. Through the Breakthrough Device designation programme, Procyrion can [...]
The PK Papyrus covered coronary stent system (Biotronik) has been named a finalist in the 2019 Prix Galien USA Awards Ceremony for Best Medical Technology. PK Papyrus is designed to be used in emergency situations to create a physical barrier to seal perforated coronary arteries without the need for invasive surgery. In September 2018, [...]
BioCardia has announced that the European Patent Office has issued the Company Patent No: 3063172 for “methods of measuring potential for therapeutic potency and defining dosages for autologous cell therapies.” A press release reports that BioCardia’s new patent is for a diagnostic approach for patient selection that identifies a specific biomarker signature in a [...]
The US FDA has granted Breakthrough Device Designation for the SeQuent Please ReX drug-coated balloon catheter (B Braun Interventional Systems) for the treatment of coronary in-stent restenosis. A press release reports that SeQuent Please ReX is the latest generation coronary drug-coated balloon catheter developed by B Braun. Ten years of extensive clinical study evaluations [...]
Ashok Seth The Myval transcatheter aortic valve implantation (TAVI) system, designed and manufactured by Meril Lifesciences in India, recently received the CE mark for the management of severe aortic stenosis. In this commentary, Ashok Seth discusses his experience with the Myval system, and the recent MyVal-1 study, one-year data of which he [...]
In a new consensus statement, the Joint UK Societies (JUKS)—which includes the British Society of Interventional Radiology—say that the evidence for renal denervation is “insufficient” to recommend its routine use in clinical practice. However, they add that they support ongoing clinical trial programmes of renal denervation and “strongly encourage” clinicians to tell their hypertensive [...]
Source: BIBA MedTech TAVI Monitor Edwards Lifesciences—in a press statement announcing its global second quarter (Q2) financial results—has revealed that it is taking the self-expanding transcatheter aortic valve implantation (TAVI) device Centera off the market. The company says resources will instead be focused on the balloon-expanding Sapien range of TAVI devices, adding [...]
EVEM 2018 Panel Report Infogram EVEM Panel Report The latest panel data for the treatment of abdominal infrarenal, complex thoracoabdominal and thoracic aneurysms and dissections.
Jet 7 Penumbra has announced the US commercial availability of its Jet 7 reperfusion catheter, which has “Xtra Flex” technology. According to a press release, the catheter is used with the Penumbra Engine in the fully integrated Penumbra system—an aspiration-based mechanical thrombectomy system that enables physicians to extract thrombus in acute ischaemic stroke [...]
Click edit button to change this text. Peregrine system kit Ablative Solutions has announced the enrolment and randomisation of the first patient in its TARGET BP I global clinical trial, which is evaluating Peregrine system kit for the treatment of patients with uncontrolled hypertension. The Peregrine system kit, which is comprised [...]
In this edition, we review (in Market Insights) the key Q1 2019 findings of the BIBA MedTech PCI Monitor—which tracks, on a quarterly basis, the percutaneous coronary intervention (PCI) procedures performed and the coronary devices used in Western Europe. We also explore the latest news (see Technology Insights) and look at pipeline developments (go [...]
Keystone Heart has signed a distribution agreement with Vasorum for sales and marketing of the Celt ACD vascular closure device. A press release reports that the Celt ACD is an arterial puncture closure device that has been used in more than 40,000 patients to date with excellent clinical results following percutaneous catheter-based vascular procedures. [...]
MitraClip XTR Abbott has received US FDA approval for fourth-generation version of its MitraClip heart valve repair device (MitraClip G4) to treat mitral regurgitation. This latest version, according to a press release, delivers an expanded range of clip sizes, an alternative leaflet grasping feature and facilitation of procedure assessment in real time [...]
Cardinal Health has announced that Stephen Mason, currently president of Cardinal Health at-Home Solutions business, has been promoted to CEO of Cardinal Health’s medical segment. Mason will succeed Jon Giacomin, who will be departing the company in mid-August to assume a CEO position at a privately-held company. A press release states that Mason is [...]
Bi-Flow LivaNova has launched its arterial femoral cannula, Bi-Flow, onto the market. The catheter, which received the CE mark earlier this year, is designed to prevent limb ischaemia during cardiac surgery that requires femoral artery cannulation. In a clinical study, a press release states, Bi-Flow was easily inserted and removed without complications [...]
A US FDA-approved, closed-loop neuromodulation system (RNS, NeuroPace) for medically refractory focal onset epilepsy is to be evaluated for managing loss-of-control eating in patients with body mass index (BMI) of 45-60 kg/m2 for whom medication and gastric bypass surgery have not been effective treatments and for whom loss-of-control eating is a contributing factor. A [...]
Medtronic and Viz.ai—which focuses on applied artificial intelligence (AI) in stroke care—have partnered to accelerate the adoption of Viz.ai's new technology, which is designed to help synchronise stroke care and decrease time to treatment, potentially improving outcomes for patients. Viz.ai's technology uses AI to identify suspected large vessel occlusion strokes and automatically notify specialists. [...]
Thanks to the use of robotics in healthcare, many procedures that were once highly invasive are now being performed using minimally invasive techniques, with the added benefits of precision and radiation protection. Jean Fajadet looks at how the technology works, and what it can bring to the cath lab. Medical robotics has become a useful [...]
av-Guardian Advent Access has received the CE mark for its av-Guardian vascular access system. A press release reports that the av-Guardian is the world’s first implant technology to pioneer the concept of establishing a “guardian guide-door” to facilitate dialysis needles to optimally access an arteriovenous (AV) fistula, without being in contact with [...]
UL International (UK) (NB 0843) has taken the decision to cease operation as a Notified Body under the Council Directive, 93/42/EEC concerning medical devices (MDD). This will be effective from 1 September 2019. A press release notes this decision is in response to a potential “no deal” Brexit, explaining that a “no deal” will [...]
Orchestra BioMed has completed a US$34 million Series B-1 Preferred Stock financing—led by institutional investors Perceptive Advisors, RTW Investments and Soleus Capital with participation from strategic partner Terumo Corporation and existing investors from SternAegis Ventures. Additionally, Orchestra BioMed may receive up to an additional $57 million in follow-on investments from existing shareholders based on [...]
IntelliCath © Fraunhofer MEVIS A novel catheter (IntelliCath, Intelligent Catheter Navigation) has been equipped with a special optical fibre containing tiny “mirrors”; these mirrors help operators see how a device moves through a patient’s vasculature, in 3D, during a procedure. Torben Pätz (Fraunhofer MEVIS, Bremen, Germany) and his co-developers have already tested [...]
Centerline Biomedical has received 510(k) clearance from the US FDA to market its flagship product, the intraoperative positioning system (IOPS). A press release reports that IOPS is a non-radiation-based surgical navigation system for minimally invasive surgery that leverages anatomical mapping algorithms and electromagnetic tracking technology to provide 3D colour visualisation and guidance in real [...]
A press release reports that the first patient has been enrolled in a prospective, multicentre trial (SIRONA II) of a pulmonary artery pressure sensor system (Cordella sensor, Endotronix), the aim of which is to valuate safety and efficacy of the system in support of its CE mark submission. Wilfried Mullens (Ziekenhuis Oost Limburg, Genk, [...]
After receiving reports of difficulty tracking and manipulating the Centera transcatheter aortic valve implantation (TAVI) system around the aortic arch, Edwards Lifesciences has issued an urgent safety notice. The notice states that these difficulties have “resulted in vascular injury including aortic dissection and death during early cases”. It adds: “A thorough investigation of these [...]
FEops HEARTguide FEops has won the CSI Frankfurt 2019’s Highlight of the Year Award for its FEops HEARTguide under the category of interventional imaging. A press release reports that this award celebrates promising technologies that will have the biggest impact in the field, on daily practice or on patients’ health and outlook. [...]
Jeffrey Shuren In a statement, published on the its website, the FDA has outlined the steps it is taking to update its Medical Device Reporting (MDR) programme—one of the tools the FDA uses to monitor device performance, detect potential device-related safety concerns or signals and contribute to the benefit-risk assessment of these [...]
Varian has signed an asset purchase agreement to acquire the Boston Scientific portfolio of drug-loadable microsphere and bland embolic bead products for treating arteriovenous malformations and hypervascular tumours. The planned acquisition of the drug-loadable microsphere (Oncozene/Embozene Tandem) and bland embolic (Embozene) bead products, a press release reports, will enable Varian to extend its new [...]
Neuronetics—a company focused on designing, developing and marketing products that improve the quality of life for patients with psychiatric disorders—has announced that Stephen Furlong will become its new chief financial officer and Secretary, replacing Peter Donato. The company’s first commercial product—the NeuroStar Advanced Therapy System—is a non-invasive and non-systemic office-based treatment that uses transcranial [...]
The European Society of Cardiology (ESC), which is the world’s largest scientific society of cardiovascular professionals, is to hold the ESC Digital Summit on 5–6 October 2019 (Tallinn, Estonia). The summit will focus on the rapid evolution of digital technology and its impact on the prevention and treatment of heart disease. Some 1,000 stakeholders [...]
Critical Innovations has received FDA breakthrough device designation for its “fast onset abdominal management” (F.O.A.M) device, which is designed to deliver a quickly-expanding foam to tamponade severe internal bleeding in trauma patients. The US Army Medical Materiel Development Activity (USAMMDA), through the Medical Technology Enterprise Consortium (MTEC), under a contract worth over one million [...]
Celling Spine—a subsidiary of Celling Biosciences—has acquired all the assets of Link Spine, which is a subsidiary of Link Orthopedics. A press release reports that Link Orthopedics is a global leader in orthopaedic technologies and was looking for a company to further develop a comprehensive spinal fusion system focused on facet fixation and minimally [...]
The Wideblue device Wideblue has developed a new medical device for Softcell Medical that measures and displays the pH of a patients’ tissue during surgery in real-time. This new pH monitoring system—comprising a pH probe and pH monitor—has been developed to assist with the assessment of patients who have either sustained injuries, [...]
Medtronic has completed the acquisition of Titan Spine; a definitive acquisition agreement between the two companies was previously announced on 9 May 2019. A Medtronic press release reports that the acquisition of Titan Spine strengthens Medtronic’s position as a leading innovator in procedural solutions for spinal surgery. The press release adds that Titan Spine [...]
Vascular Perfusion Solutions (VPS) has developed a first-of-its-kind medical device—Ulisses—with the aim of preserving and resuscitating vascularised tissue in both organs and limb for more than 24 hours. A press release reports that, move to the next level of research with the device, VPS launched a GoFundMe campaign to raise funds to advance the [...]
Jonathon A Leipsic The 2019 DeHaan Award for Innovation in Cardiology has been awarded to Jonathon A Leipsic, who is a professor of radiology and cardiology at the University of British Columbia (Vancouver, Canada). The award includes a US$200,000 grant and Leipsic will present the second Dehaan Award Lecture at the Society of [...]
BioMonitor III After receiving the CE mark, Biotronik has launched its next-generation injectable cardiac monitor (ICM)—BioMonitor III—onto the European market. A press release reports that the novel device is designed to help patients with irregular heart rhythms by documenting suspected arrhythmia or unexplained syncope with increased clarity. Aiming to improve the accuracy [...]
The Centers for Medicare & Medicaid Services (CMS) has finalised its update the US coverage for transcatheter aortic valve implantation (TAVI). It will continue to provide coverage with evidence development when furnished according to an FDA-approved indication. However, it has updated the coverage criteria for hospitals and physicians to begin or maintain a TAVI [...]
A company providing what a press release calls “next-generation electrophysiology technology solutions” has announced that it now has US$170m financing. The press release reports that this includes a US$100 million Series D equity financing and a US$70 million credit facility. It states that the funding is intended to accelerate commercialisation and facilitate global business [...]
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