Evolut now has CE mark for low-risk patients and has new labelling for bicuspid use

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 [...]

2020-06-23T11:39:41+00:00June 23rd, 2020|Tags: , , |

Foldax closes US$20 million financing

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 [...]

2020-06-23T11:23:10+00:00June 23rd, 2020|Tags: , , , , |

Rexgenero acquires assets of aratinga.bio SAS Group

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 [...]

2020-06-23T11:17:08+00:00June 23rd, 2020|Tags: , , |

Abiomed initiates online education platform for PCI

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 [...]

2020-06-19T11:37:19+00:00June 19th, 2020|Tags: , , |

Vaseem Mahboob steps down as CFO of Endologix

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 [...]

2020-06-19T11:32:45+00:00June 19th, 2020|Tags: , |

Smartphone could be used to detect fluid in the lungs

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 [...]

2020-06-19T11:27:30+00:00June 19th, 2020|Tags: , |

Medtronic receives US FDA approval for Cobalt and Crome implantable ICDs

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, [...]

2020-05-11T15:54:02+00:00May 11th, 2020|Tags: , , |

Cook Medical and Surmodics reach distribution agreement for two new vascular products

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 [...]

2020-05-11T15:49:16+00:00May 11th, 2020|Tags: , , |

Terumo Aortic announces FDA approval for Treo endovascular device

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 [...]

2020-05-11T15:56:25+00:00May 11th, 2020|Tags: , , |

FDA clears Aspire MAX mechanical thrombectomy system

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 [...]

2020-05-11T15:40:56+00:00May 11th, 2020|Tags: , |

Wearable necklace-ECG can detect abnormal heart rhythm

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 [...]

2020-05-11T15:36:58+00:00May 11th, 2020|

LifeSignals receives CE mark for the ECG Remote Monitoring Patch

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 [...]

2020-05-11T15:27:53+00:00May 11th, 2020|Tags: , |

CE mark for SuperSaturated oxygen therapy

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 [...]

2020-05-11T15:20:51+00:00May 11th, 2020|Tags: , , , |

Newer generations of MitraClip associated with greater reduction in mitral regurgitation than previous version

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 [...]