P+F’s TricValve System Granted FDA Breakthrough Device Designation

December 22, 2020—P+F Products + Features GmbH announced that FDA has granted Breakthrough Device designation for the company’s TricValve transcatheter bicaval valves system.

The TricValve is currently undergoing CE certification process. CE Mark approval is expected in Q1 2021, advised P + F, which is based in Vienna, Austria.

According to the company, 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 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.

Professors Samir Kapadia, MD, and Rishi Puri, MD, of the Cleveland Clinic in Cleveland, Ohio, commented in the company’s announcement, “The TricValve system represents a new technology offering a potentially simple, relatively low-risk yet effective treatment for patients with symptomatic severe tricuspid regurgitation 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 United States to further evaluate its safety and efficacy.”