Edwards Lifesciences received FDA approval for its SAPIEN 3 transcatheter prosthetic heart valve to be used for valve-in-valve procedures. Indicated for placement within both the aortic and mitral valves in patients at risk of undergoing open heart surgery to remove an existing valve, the SAPIEN 3 can reside within a previously implanted bioprosthetic valve that has begun to fail.

The device was previously approved in the U.S. for treatment of severe, symptomatic aortic stenosis in patients at high risk for open-heart surgery, as well as for patients that are at intermediate risk for open-heart surgery that would benefit from the SAPIEN 3.

“This approval brings a safe and effective transcatheter therapy to patients who would do very poorly with repeat open-heart surgery,” said John Carroll, M.D., professor of cardiology at the University of Colorado School of Medicine and director of interventional cardiology at the University of Colorado Hospital, Denver and member of the TVT Registry Steering Committee. “I am pleased to see that the FDA recognizes the value of the high-quality evidence generated by the STS-ACC TVT Registry and its ability to play an important role in assessing ‘real-world’ clinical results in specialty indications, such as valve-in-valve, and for particular patient groups, such as those needing replacement of a bioprosthetic mitral valve.”

Flashbacks: Edwards SAPIEN 3 Aortic Heart Valve Approved in U.S…Edwards Sapien 3 Prosthetic Aortic Heart Valve Approved in Europe…

Product page: Edwards SAPIEN 3 Transcatheter Heart Valve…

Via: Edwards…