Corvia Medical said today that it won FDA breakthrough device designation for its interatrial shunt device for heart failure. The Tewksbury, Mass.-based company’s interatrial shunt is designed to lower blood pressure in the left atrium and lungs by creating a small opening between the left and right atria. It’s the world’s first transcatheter device indicated […]
Cardiac Implants
Study: Abbott, Edwards may have mislabeled hundreds of patient deaths
This report has been updated with comments from Edwards Lifesciences, Madris Tomes and the FDA. Abbott (NYSE:ABT) and Edwards Lifesciences (NYSE:EW) may have mislabeled patient deaths as injuries or device malfunctions in hundreds of FDA adverse event reports involving their transcatheter aortic or mitral valve replacement devices, according to a new study. The study by JAMA […]
BioVentrix launches trial for Revivent TC heart failure device
BioVentrix said today that it enrolled and treated the first patient in its Revive-HF European trial to evaluate the Revivent TC system for the treatment of ischemic cardiomyopathy-induced heart failure. The patient, who had suffered a heart attack that resulted in left ventricle scarring and ischemic heart failure, was successfully implanted with three anchor pairs […]
Medtronic launches trial for extravascular ICD
Medtronic (NYSE:MDT) said today that it launched a worldwide pivotal study to evaluate its extravascular implantable cardioverter defibrillator device for treating dangerously fast heart rhythms. The EV ICD system uses a device that is the same size as traditional, transvenous ICDs, but with a lead wire placed outside the heart and veins, designed to deliver defibrillation […]
Report: Docs could reduce adverse events with Boston Sci’s Watchman
This article has been updated to include comments from Boston Scientific. A recent review of FDA files has found nearly 3,000 adverse events related to Boston Scientific’s (NYSE:BSX) Watchman device. The Watchman left atrial appendage closure device, approved by the agency in March 2015, is designed to prevent blood clots that form in the heart’s […]
Gore wins CE Mark for Cardioform ASD septal occluder
W.L. Gore said yesterday that it won CE Mark approval in the European Union for its Cardioform ASD septal occluder for the percutaneous, transcatheter closure of ostium secundum atrial defects. The device won pre-market approval from the FDA for Cardioform ASD in June. The device is designed to close atrial septum defects of 8mm to 35mm […]
FDA approves early feasibility study for new Medtronic TMVR
Medtronic (NYSE:MDT) said today that it has received FDA approval to begin an early feasibility study for its Intrepid transcatheter mitral valve replacement (TMVR) system using a minimally-invasive transfemoral access approach. The announcement builds upon primary endpoint outcomes of the Intrepid TMVR Apollo clinical trial using the transapical approach, published in the Journal of the […]
Abbott wins CE Mark for pediatric heart devices
Abbott (NYSE:ABT) said today that it won CE Mark approval for its Masters HP mechanical heart valve and Amplatzer Piccolo occluder. The Masters HP is the world’s smallest mechanical heart valve (15mm) and is designed for implantation in the mitral or aortic position to mimic a healthy heart valve by opening and closing to facilitate blood […]
Corvia Medical taps PhysIQ for remote monitoring in interatrial shunt study
Corvia Medical said it launched a heart failure device trial that will include the collection and analysis of data with PhysIQ’s continuous remote monitoring platform. The Phase III trial is designed to evaluate the efficacy of Tewksbury, Mass.-based Corvia’s interatrial shunt in patients with heart failure. The randomized, controlled, double-blinded study includes plans to provide […]
Man charged in death of Medtronic research scientist
This article has been updated with charging information from the Hennepin County (Minn.) Attorney’s Office. Officials in Minneapolis have charged a man with manslaughter in the August 23, 2019, death of a Medtronic research scientist. Hennepin County officials said they have charged Erik Kravchuk, 28, of Golden Valley, Minn. with first-degree manslaughter in the death […]
V-Wave’s interatrial shunt lands another breakthrough nod from FDA
V-Wave said yesterday that it won FDA breakthrough device designation for its interatrial shunt for pulmonary arterial hypertension, marking the second time in less than a month that the company has earned a breakthrough nod. The PAH shunt is designed to be placed in the heart through a catheter inserted via a vein in the […]