Cardiovalve is developing cardiovascular replacement devices for minimally invasive surgery.

Its flagship system is designed to replace the mitral valve using a transfemoral system. Cardiovalve is designed from the bottom up for transfemoral/transseptal delivery with femoral venous access. This approach offers significant benefits including a short profile for minimal protrusion to the left ventricle, minimizing interference in the cardiac blood flow, and increased safety.

The company aims to bring to market a viable, clinically proven transfemoral alternative to open-heart surgery in which mitral regurgitation treatments are easier to perform for physicians, enabling patients to return to a healthy life after a quicker recovery.

Cardiovalve received FDA approval for an Early Feasibility Study of its Transcatheter Tricuspid Valve Replacement System for a tricuspid regurgitation indication. The Cardiovalve System has also been granted Breakthrough Device Designation status by the FDA. Cardiovalve is a spin-off of Valtech Cardio, which was acquired by Edwards Lifesciences in 2017.