FDA Grants Breakthrough Device Status For Cardiovalve Transcatheter Tricuspid Valve Replacement System

Cardiovalve announced today that it has received U.S. Food and Drug Administration (FDA) approval for an Early Feasibility Study (EFS) of its Transcatheter Tricuspid Valve Replacement System for a tricuspid regurgitation (TR) indication. The Cardiovalve System also has been granted ‘Breakthrough Device Designation’ status by the FDA.

Cardiovalve is the first privately held company to have the FDA’s EFS approval for both TR and MR (tricuspid/mitral regurgitation) indications.

“I am excited to finally have a truly percutaneous approach for treating TR. The Cardiovalve System is an innovative solution for an unmet clinical need,” said Dr. Azeem Latib, Medical Director of Structural Heart Interventions at Montefiore Medical Center’s Department of Cardiology in New York City. As primary investigator for the U.S. TR study, Dr. Latib will be presenting details of Cardiovalve’s technology and procedure, as well as the clinical EFS design, at the upcoming ‘CRT2020’ scientific conference on Sunday, Feb. 23, at 3:00 p.m. EST in room ‘Potomac C’ at Gaylord National Convention Center, National Harbor, Md.

Amir Gross, CEO of Cardiovalve, added: “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.”

Cardiovalve commenced its Early Feasibility Study for TR in the U.S. 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 5 years. The study will be conducted in collaboration with five leading US hospitals.

Cardiovalve has developed an innovative transfemoral valve replacement system where the valve mimics 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.

“I have previously successfully performed initial First-in-Human cases with the Cardiovalve MR procedure. Now, the Cardiovalve system can be utilized in the Tricuspid location with the same transcatheter procedure. In fact, the Tricuspid is simpler and faster and, therefore, I anticipate similar procedural success,” explained Prof. Francesco Maisano, Head of Cardiovascular Surgery at Zurich University Hospital, Switzerland.

About Cardiovalve: A Novel Transcatheter Valve System
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. The flagship Cardiovalve transcatheter system is a novel valve replacement device designed for transfemoral use to replace the native Mitral/Tricuspid 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.

The Cardiovalve system is designed to provide significant benefits, including a short profile for minimal protrusion to the left or right ventricle, minimizing interference with the cardiac blood flow (outflow tract obstruction) with an aim of improving safety and avoiding surgical risk; it has a robust design, as well as an enhanced sealing solution to prevent paravalvular leaks. Currently, the valve has three sizes to fit varying anatomies. Initial clinical results are promising with high procedural success, and first patients demonstrating the durability of the implant have maintained clinical benefit for more than two years. The AHEAD U.S. EFS IDE studies for both the mitral and tricuspid indications are approved and currently enrolling subjects in five centers in the U.S. The AHEAD EU Study for the Mitral indication is enrolling subjects at multiple centers in Europe, including Germany, Italy, Lithuania and Switzerland.-Business Wire