Edwards lands CE Mark for pulmonic transcatheter heart valve

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The European Union has granted Edwards Lifesciences a CE Mark for its Sapien pulmonic transcatheter heart valve to treat congenital heart disease.

The heart valve can be used in pediatric patients as a minimally invasive alternative to the surgical approach to valve replacement, according to the company, which added that the Sapien is deployed after the RetroFlex 3 transfemoral delivery system is threaded through a patient’s circulatory system.

Sapien is pending approval in the U.S. and is currently an investigational device being assessed by the COMPASSION (Congenital Multicenter trial of Pulmonic vAlve regurgitation Studying the SAPIEN InterventIONal THV) trial.