News | Structural Heart | January 06, 2021

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. #TTVR

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.

For more information: https://productsandfeatures.com

 

Find more transcatheter valve news and video

Related Content

Among high-risk, chronic, coronary patients who undergo angioplasty, there were no additional benefits from ticagrelor compared to the current standard of care clopidogrel. #AHA #AHA20 #AHA2020
News | Cath Lab | November 16, 2020
November 16, 2020 — The use of the more potent antiplatelet medication ticagrelor (Brilinta) was not superior to clop
A large subgroup analysis of the VOYAGER PAD randomized clinical trial showed neither a mortality risk nor benefit associated with the use of paclitaxel drug-coated devices (DCD) in the treatment of peripheral artery disease (PAD). The study also found that the benefit of rivaroxaban use on reducing ischemic limb and cardiovascular outcomes was consistent regardless of whether a DCD was used. #TCT2020 #TCTconnect
Feature | Cath Lab | October 18, 2020
October 18, 2020 – A large subgroup analysis of a randomized clinical trial showed neither a mortality risk nor benef
A longitudinal vessel assessment may demonstrate co-existence of multiple plaque morphologies on OCT, including superficial calcification with thrombus, healed plaque, plaque rupture, lipidic plaque with a thin capped fibrous atheroma (TCFA). #TCTconnect #TCT2020

A longitudinal vessel assessment may demonstrate co-existence of multiple plaque morphologies on OCT, including superficial calcification with thrombus, healed plaque, plaque rupture, lipidic plaque with a thin cap fibro-atheroma (TCFA).

News | Cath Lab | October 18, 2020
October 18, 2020 – Data from the...
The DISRUPT CAD III study showed intravascular lithoplasty from Shockwave Medical was effective in breaking up calcified coronary lesions. #TCT2-0

The DISRUPT CAD III study showed intravascular lithoplasty from Shockwave Medical was effective in breaking up calcified coronary lesions.

Feature | Cath Lab | October 16, 2020
October 15, 2020 — Shockwave Medical's Intravascular Lithotripsy (IVL) system to treat severely calcified coronary ar
Videos | Cath Lab | October 16, 2020
This is an example pf the Shockwave Medical Intravascular Lithotripsy (IVL) catheter system designed to break up heav
Videos | Cath Lab | July 15, 2020
Richard Botto, CVT, RCSA, chief cardiovascular technologist, division of cardiology, cardiac cath lab, offers an over
Videos | Cath Lab | July 13, 2020
The Vieussens’ arterial ring (VAR) is a connection between the conus artery and the left anterior descending (LAD) co
News | Cath Lab | July 06, 2020
July 6, 2020 — Black patients who undergo percutaneous coronary intervention (PCI) are at an increased risk for major