IRVINE, Calif., June 5, 2017 — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it has received U.S. Food and Drug Administration (FDA) approval for aortic and mitral valve-in-valve procedures using the Edwards SAPIEN 3 transcatheter heart valve. The SAPIEN 3 valve is the first transcatheter heart valve approved in the U.S. for the treatment of both aortic and mitral patients who are at high risk for a subsequent open-heart surgery to replace their bioprosthetic valve.
“Expansion of the SAPIEN 3 device indication to include valve-in-valve procedures is a meaningful advancement for patients at high risk of an additional open-heart valve procedure, particularly for those in need of a safe alternative for mitral valve replacement,” said Larry L. Wood, Edwards’ corporate vice president, transcatheter heart valves.
This anticipated FDA approval of the indication expansion was supported by real-world data collected from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry. The TVT Registry includes information and outcomes on patients undergoing transcatheter valve replacement and repair procedures in the United States.
Read full press release here at Edwards.com
Source: edwards.com
