FDA Grants Break Through Device Designation for TricValve Transcatheter Bicaval Valves System

Designation as Breakthrough Device by the U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) has granted the designation of breakthrough device to P+F Products + Features GmbH TricValve Transcatheter Bicval Valves System. The system uses two self-expanding valves in the vena cava for the treatment of patients with hemodynamically relevant tricuspid insufficiency without the need to touch the native tricuspid valve.

January 6, 2021—The U.S. Food and Drug Administration (FDA) has granted the designation of breakthrough device to P+F Products+Features GmbH TricValve Transcatheter Bicval Valves System.

The FDA granted this status December 15, 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 Samir Kapadia, M.D., chairman of the Department of Cardiovascular Medicine, and Rishi Puri, M.D., Ph.D., 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, Katharina Kiss, M.D.

The TricValve is currently undergoing CE certification process. CE mark is expected in the first quarter of 2021.

P+F is developing a pipeline of transcatheter heart valves and grafts, as well as the Aortasave, a transcatheter endobentall solution for aortic dissection.

参考文献 https://www.dicardiology.com/content/fda-grants-break-through-device-designation-tricvalve-transcatheter-bicaval-valves-system

来源：医心