Edwards Sapien Pulmonic Valve Approved in Europe

May 26, 2010—Edwards Lifesciences (Irvine, CA) announced the receipt of CE Mark approval for the Edwards Sapien pulmonic transcatheter heart valve (THV). The valve is designed as an alternative to surgical valve replacement for patients with congenital heart disease of the pulmonic valve. The company noted that the Sapien pulmonic valve's leaflet design is modeled after the company's aortic tissue valves, which have a bovine pericardial tissue valve, stainless steel frame for high radial strength, and are delivered with the RetroFlex 3 transfemoral delivery system.

Edwards advised that the valve is an investigational device in the United States, where the safety of the valve is being assessed in the COMPASSION (Congenital Multicenter Trial of Pulmonic Valve Regurgitation Studying the Sapien Interventional THV) clinical trial. The company completed its feasibility study of the valve and is progressing into the pivotal portion of the clinical trial with the goal of receiving a Humanitarian Device Exemption from the US Food and Drug Administration. Ziyad M. Hijazi, MD, is the principal investigator of the COMPASSION clinical trial.