Edwards Sapien XT Approved in Europe for Mitral and Aortic Valve-in-Valve Procedures

February 5, 2014—Edwards Lifesciences (Irvine, CA) announced it has received European CE Mark approval for valve-in-valve procedures using the company’s Sapien XT transcatheter heart valve for patients whose surgical mitral or aortic valves require replacement and who are at extreme risk for surgery. Edwards stated that valve-in-valve indication for the mitral position addresses an unmet need for clinicians by providing an alternative to a high-risk surgery.

Olaf Wendler, MD, Professor of Cardiac Surgery at King's College Hospital in London, United Kingdom and one of the principal investigators of the SOURCE XT registry, commented on the European approval of the new indication in the company’s press release.

“Just as native heart valves experience wear over time, bioprosthetic valves eventually degenerate too, creating a need for a replacement valve,” stated Dr. Wendler. “The European adoption of valve-in-valve procedures using Sapien XT is an important development for treating patients who may otherwise go untreated. In particular, patients needing a reoperation to address a failing mitral valve face a very challenging surgery, and the ability to offer a transcatheter replacement is extremely important for this patient group.”

Edwards advised that the Sapien XT valve is not commercially available in the United States, where it is an investigational device being studied as part of the randomized, pivotal PARTNER II trial.