FDA Okays Sapien 3 for Mitral, Aortic Valve-in-Valve Replacement

June 05, 2017

WASHINGTON, DC — The US Food and Drug Administration has expanded the Sapien 3 THV (Edwards Lifesciences) approval indication to include transcatheter "replacement" of failed bioprosthetic valves in either the aortic or mitral valve positions in high-surgical-risk patients[1].

The FDA says the new expanded indication represents the first approval of any transcatheter valve for so-called "valve-in-valve" procedures on not only aortic prostheses, but also mitral prostheses that have failed. The expanded indication is limited to patients deemed "at high or greater risk of death or serious complications from traditional open-heart surgery."

The Sapien 3 is already approved for transcatheter aortic-valve replacement (TAVR) of native valves in patients deemed at high or intermediate surgical risk.

The expanded indication is based on analyses from the Transcatheter Valve Therapy Registry (TVTR), jointly sponsored by the American College of Cardiology (ACC) and the Society of Thoracic Surgeons (STS).

In that Sapien 3 experience, among 314 patients with aortic valve-in-valve procedures and 311 with mitral valve-in-valve procedures, more than 85% showed clinically meaningful improvement in NYHA heart-failure functional class, according to the agency. And "in both aortic and mitral valve-in-valve patients, the observed mortality rates were substantially lower than the expected mortality rate for repeat surgery."

Edwards Lifesciences will participate in the STS/ACC TVTR for continued surveillance of the Sapien 3 for 5 years, the FDA said.

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