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

VERITAS Vision System Is Introduced by Johnson & Johnson

The company will offer live demos of the new system in a wet lab at the Johnson & Johnson booth (#2813) this weekend at the 2021 American Society of Cataract and Refractive Surgery and American Society of Ophthalmic Administrators Annual Meeting.

GenesisCare Orders 27 Elekta Flexitron Treatment Devices

"GenesisCare continues to demonstrate its commitment to improving patient outcomes worldwide and Elekta is delighted to play a vital partnering role to achieve this mission," said Gustaf Salford, Elekta's President and CEO.

FoodMarble AIRE Shown to Exceed the Performance of ‘Gold Standard’ SIBO Testing in Clinical Trial

SIBO is a very common disorder where there are excessive bacteria present in the small intestine. The true prevalence of SIBO in the general population is largely unknown, with some studies estimating its occurrence in up to 15% of healthy individuals. It is also largely associated with many other common clinical conditions, including irritable bowel syndrome, where 40-80% of IBS patients have SIBO.

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.

spot_img

DON'T MISS

Our Sister Publication: Biotechnology News Magazine

Subscribe to Medical Device News Magazine here.