December 22, 2020
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.
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 Cardiology, Cleveland Clinic.
The dedicated TricValve® bioprostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve.
They are especially intended for use for patients at extreme risk or who are inoperable for open surgical therapy. The valves come fully pre-mounted thus facilitating the use of this innovative device in daily clinical practice.
“It is a huge milestone to receive the breakthrough device status for the TricValve®. This could be a big change in the treatment of patients with severe TR made in Europe,” said CEO of P+F, Dr. Katharina Kiss.
The TricValve® is currently undergoing CE certification process. CE mark is expected in Q1 2021.