A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

TricValve Transcatheter Bicaval Valves System Granted Designation as Breakthrough Device by the FDA on December 15, 2020

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.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The Evolut ™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access
The study was an analysis of AstraZeneca’s Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF). The patient data from the trial was processed with Brainomix’s e-Lung tool. The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
“Since the algorithm for matching patients with donors is changing across for all organs, this was a prime time to better understand whether transplant team decisions to accept a donated organ varied by patient race and gender,” she said. “We wanted to understand how the process of receiving a transplant after listing varied by race and gender, and the combination of the two, so that steps can be taken to make that process more equitable," said Khadijah Breathett, MD.
The Mount Sinai study found that primary care physicians’ approach reflects a dearth of evidence-based guidance for lung cancer screening shared decision-making in patients with complex comorbidities
This is the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.

By using this website you agree to accept Medical Device News Magazine Privacy Policy