Before the coronavirus pandemic hit, medtech companies large and small were making notable news with a number of innovative heart devices. Some of these same companies took a big hit to their bottom lines when the danger of spreading COVID-19 and using up precious personal protective equipment convinced hospitals to limit non-urgent procedures. Now hospitals […]
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Cardiovalve scores FDA wins for its transcatheter tricuspid valve replacement tech
Cardiovalve (Or Yehuda, Israel) said today that U.S. FDA has granted a breakthrough device designation for its transcatheter tricuspid valve replacement system. FDA also approved an early feasibility study of the system for a tricuspid regurgitation (TR) indication. Cardiovalve touted that it is the first privately held company to have the FDA early feasability study […]
Cardiovalve launches pivotal TMVR trials
Israel cardiovascular device developer Cardiovalve said yesterday it launched both the Ahead US and Ahead EU multicenter studies of its Cardiovalve transfemoral mitral valve replacement system. The company’s flagship Cardiovalve system is a novel mitral valve designed for either transferal or transeptal use and is intended to replace the mitral valve through a minimally invasive […]
