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.
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