Edwards
SAPIEN 3
Cardiac Valve FDA
Approved for
Mitral and
Aortic Valve-in-Valve Procedures
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 ste**sis 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…
