Abbott (NYSE:ABT) announced today that CMS revised its coverage for TMVR, opening up new possibilities for its MitraClip device. The CMS National Coverage Determination (NCD) expands coverage for transcatheter mitral valve repair (TMVR) to include patients with secondary (or functional) mitral regurgitation (MR) resulting from heart failure. According to an Abbott news release, the CMS decision […]
Cardiac Implants
These medtech stocks performed the best in 2020
While 2020 did not go as planned for anyone, with the twists and turns came opportunities for medtech companies to power forward. Innovations came both as a result of the COVID-19 pandemic and perhaps in spite of the challenges brought on by the virus, highlighted by the increased efforts to produce vaccines and testing while […]
Apple magnetic charger, smartwatch may deactivate Medtronic ICD
A new study in the Heart Rhythm Journal showed a magnetic charger for the iPhone 12 was able to deactivate a Medtronic implantable cardioverter defibrillator (ICD). The iPhone 12 has a circular array of magnets deployed around a central charging coil, making it compatible with the company’s wireless “MagSafe” accessories, according to the study published Jan. 4, […]
Boston Scientific’s preliminary Q4 results show 6.8% revenue decline
Boston Scientific (NYSE:BSX) announced today that its fourth-quarter net sales represent an approximate decline of 6.8% year-over-year. Marlborough, Mass.-based Boston Scientific’s estimation of $2.71 billion in fourth-quarter revenue brings its full-year 2020 sales total to approximately $9.91 billion, marking a 7.7% total decline from 2019. Wall Street analysts on average had predicted $2.86 billion in revenue […]
Medtronic’s Kowal explains how remote medtech got its groove back
In this week’s DeviceTalks Weekly Podcast, Dr. Robert Kowal CMO of Medtronic’s cardiac rhythm and heart failure business and vice president of medical affairs, explains how new tech, savvy patients, eager physicians and, yes, COVID-19, has fueled a renaissance for remote technology, once seen as a mature, staid business. Kowal, who left clinical practice to […]
CorWave raises $40m in funding for breakthrough heart pump
CorWave announced today that it raised $40 million from a mix of returning and new investors for its wave membrane heart pump. Clichy, France-based CorWave received funding — from three new investors joining its returning investors — which is earmarked for its implantable left ventricular assist device (LVAD) which uses its breakthrough wave membrane pump […]
TricValve transcatheter bicaval valves system wins FDA breakthrough designation
P+F Products + Features GmbH announced that it received FDA breakthrough device designation for its TricValve system. Vienna-based P+F received the breakthrough nod earlier this month for the transcatheter bicval valves system, comprised of two self-expanding biological valves for the treatment of patients with hemodynamically relevant tricuspid insufficiency and caval reflux, according to a news […]
Medtronic gains Health Canada nod for Micra AV pacemaker
Medtronic Canada (NYSE:MDT) announced that it received a Health Canada license for its Micra AV pacemaker with atrioventricular synchrony. Brampton, Ontario-based Medtronic Canada said in a news release that Micra AV is indicated for treating patients with AV block, making it the first and only Health Canada-licensed leadless pacemaker portfolio. The pacemaker won FDA approval in […]
Health Canada gives Edwards’ Sapien 3 TAVR expanded use nod
Edwards Lifesciences (NYSE:EW) today announced that Health Canada has approved the expanded use of the company’s Sapien 3 and Sapien 3 Ultra transcatheter heart valves to treat patients diagnosed with severe symptomatic aortic stenosis who are at low risk for open-heart surgery. The Sapien 3 valves are the first transcatheter aortic valve replacement (TAVR) systems to […]
FDA approves Abbott Heartmate 3 label update in pediatric patients
Abbott (NYSE:ABT) announced that the FDA approved updated labeling for its HeartMate 3 heart pump for pediatric patients. The heart pump can now be used in pediatric patients with advanced refractory left ventricular heart failure, giving physicians more options for treating the pediatric population awaiting a heart transplant or ineligible for receiving a transplant due to […]
Corvion gains FDA breakthrough nod for LVAD
Corvion announced that it received FDA breakthrough device designation for its left ventricular assist device (LVAD). Webster, Texas-based Corvion said in a news release that the breakthrough nod for the fully implanted LVAD device allows the company to move forward with the FDA in addressing topics that arise during development and testing ahead of an […]
