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TricValve Transcatheter Bicaval Valves System granted Designation as Breakthrough Device by the U.S. Food and Drug Administration (FDA) Transcatheter Bicval Valves System by the U.S. Food & Drug Administration on December 15 th 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 forward to clinical trials in the US to further evaluate its safety and efficacy, said Prof. Samir Kapadia, Chairman Dept. of Cardiovascular Medicine and Prof. Rishi Puri, Interventional C ....
TricValve® Transcatheter Bicaval Valves System granted Designation as Breakthrough Device by the U.S. Food and Drug Administration (FDA) 22/12/2020 - 16:10 ); ); 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 ....