Sapien XT valve gains European approval for transcatheter mitral, aortic valve-in-valve procedures

Edwards Lifesciences Corporation announced that it has received CE Mark in Europe for valve-in-valve procedures using the Sapien XT transcatheter heart valve, according to a press release.

The approval provides a minimally invasive treatment option for patients whose surgical mitral or aortic valves require replacement as well as those who are at extreme risk for surgery. Edwards Lifesciences is the only company to receive a valve-in-valve indication for the mitral position, according to the release.

“The European adoption of valve-in-valve procedures using Sapien XT is an important development for treating patients who may otherwise go untreated,” Olaf Wendler, MD, PhD, professor of cardiac surgery at King’s College Hospital, London, stated in the release. “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.”

The Sapien XT valve is not commercially available in the United States, but is under investigation as part of the PARTNER II trial, according to the release.

Disclosure: Wendler is a paid consultant for Edwards Lifesciences Corporation.