Cardiovalve has received FDA approval for an early feasibility study of its transcatheter tricuspid valve replacement system for a tricuspid regurgitation indication; the Cardiovalve system also has been granted Breakthrough Device Designation status by the FDA. Cardiovalve commenced its study for tricuspid regurgitation in the USA earlier this year. The study’s primary endpoint is the safety and feasibility of the Cardiovalve technology and procedure in reducing tricuspid regurgitation, with evaluations at 30 days and periodically up to five years. The study will be conducted in collaboration with five leading US hospitals.

A press release states that Cardiovalve has developed an innovative transfemoral valve replacement system in which the valve has been designed to mimic current surgical replacement solutions that can fit both mitral and tricuspid indications, covering 90% of the patient population with three approved valve sizes, using the same delivery system.

Azeem Latib (Department of Cardiology, Montefiore Medical Center, York, USA), a primary investigator for the study, says: “I am excited to finally have a truly percutaneous approach for treating tricuspid regurgitation. The Cardiovalve system is an innovative solution for an unmet clinical need.”

Originally part of Valtech Cardio, which was acquired by Edwards Lifesciences in 2017, Cardiovalve operates under the leadership of Amir Gross, Valtech’s co-founder and CEO. Its Cardiovalve transcatheter system is a novel valve replacement device designed for transfemoral use to replace the native mitral/yricuspid regurgitating valve by using a transfemoral procedure. The system offers an approach that avoids the need for open surgery or transapical delivery with mini-thoracotomy access.

Gross comments: “We are excited about the FDA’s recognition of the potential clinical benefit of the transcatheter tricuspid valve replacement system. We now have clinical data two years out that our implant is functioning as expected and the patient is improved clinically. FDA’s ‘breakthrough’ designation validates and reaffirms our commitment to improving and extending the lives of millions of patients suffering from heart valve disease across the world.”