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February 20, 2020

FDA Approves Early Feasibility Study and Grants Breakthrough Device Designation for Cardiovalve System

February 20, 2020—Cardiovalve announced that it has received FDA approval for an early feasibility study (EFS) of its transcatheter tricuspid valve replacement system for a tricuspid regurgitation (TR) indication. Additionally, the company noted that the Cardiovalve system has been granted Breakthrough Device designation by the FDA. The FDA previously approved an EFS for the Cardiovalve system for a mitral regurgitation indication.

According to the company, the Cardiovalve system design includes a short profile for minimal protrusion to the left or right ventricle, minimizing interference with the cardiac blood flow (outflow tract obstruction) with the aim of improving safety and avoiding surgical risk. The device’s enhanced sealing solution prevents paravalvular leak.

Cardiovalve’s transfemoral valve replacement system mimics current surgical replacement solutions that can fit both mitral and tricuspid indications, covering 90% of the patient population with three approved valve sizes to fit varying anatomies, using the same delivery system.

Earlier this year, Cardiovalve commenced the EFS for TR in the United States. The study’s primary endpoint is the safety and feasibility of the Cardiovalve technology and procedure in reducing TR, with evaluations at 30 days and periodically up to 5 years. The study will be conducted in collaboration with five leading United States hospitals.

The AHEAD US EFS investigational device exemption studies for the mitral and tricuspid indications are approved and currently enrolling patients in five centers in the United States. The AHEAD EU study for the mitral indication is enrolling patients at multiple centers in Europe, including Germany, Italy, Lithuania, and Switzerland.

Initial clinical results are promising with high procedural success, and the durability of the implant has been demonstrated in maintaining clinical benefit for more than 2 years in the first patients treated with the device, stated the company.

Azeem Latib, MD, serves as Primary Investigator for the United States TR study. Dr. Latib will be presenting details of Cardiovalve’s technology and procedure, as well as the clinical EFS design, at CRT 2020, the Cardiovascular Research Technologies scientific conference held February 22–25 in National Harbor, Maryland. Dr. Latib is Medical Director of Structural Heart Interventions at Montefiore Medical Center’s Department of Cardiology in New York, New York.

In the company’s press release, Dr. Latib commented, “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.” Additionally, Professor Francesco Maisano, MD, stated, “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,” Prof. Francesco Maisano is Head of Cardiovascular Surgery at Zurich University Hospital in Zurich, Switzerland.

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