NATIONAL HARBOR, Md. – Cardiovalve Ltd., of Or Yehuda, Israel, scored a double hit with the U.S. FDA, winning a breakthrough device designation for its transcatheter tricuspid valve replacement system, as well as approval to conduct an early feasibility study in tricuspid regurgitation (TR).
Abbott Laboratories has received CE mark approval for its Tendyne transcatheter mitral valve implantation (TMVI) system, the first such device approved for use in Europe and the world. The system is intended for patients with leaky mitral valves that are beyond repair and those at high risk for open heart surgery.
TORONTO – Several U.S. and Canadian patients have recently undergone successful mitral valve surgery featuring a platform designed by Toronto-based Baylis Medical Inc. to provide more precise access to the wall separating the left and right sides of the heart. Robert Harrison, Baylis's director of research and development for cardiology, said in addition to locating the precise puncture point for mitral valve reconstruction, the Versacross transseptal solution has reduced the number of devices exchanged during the procedure to an all-in-one platform.
Abbott Laboratories had a busy Transcatheter Cardiovascular Therapeutics (TCT) 2019 conference. Among the news it generated was the unveiling of new analyses of the COAPT trial on the cost-effectiveness of Mitraclip vs. guideline-directed medical therapy (GDMT) alone in heart failure patients with secondary mitral regurgitation (MR).