Live Breaking News & Updates on Transcatheter Bicval Valves System

TricValve® Transcatheter Bicaval Valves System granted Designation as Breakthrough Device by the U.S. Food and Drug Administration (FDA)
22/12/2020 - 16:10
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VIENNA, Dec. 22, 2020 /PRNewswire/ P+F Products + Features GmbH has been granted designation as a Breakthrough Device for the company s lead product, the TricValve® Transcatheter Bicval Valves System by the U.S. Food & Drug Administration on December 15th 2020. The TricValve® is a system of two self-expanding biological valves for the treatment of patients with hemodynamically relevant tricuspid insufficiency and caval reflux. The TricValve® system represents a new technology offering a  potentially simple, relatively low-risk yet effective treatment for patients with symptomatic severe tricuspid regurgitation (TR) and heart failure, many of whom harbor anatomy unfavorable for edge-to-edge repair or direct annuloplasty. It allows for all future options as patients stabilize and improve. We look f ....

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