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 [...]
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, [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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, [...]
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 [...]
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. [...]
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 [...]