Edwards Lifesciences has announced it has received CE Mark for its self-expanding CENTERA valve for severe, symptomatic aortic stenosis patients at high risk of open-heart surgery. The Edwards CENTERA valve is repositionable and retrievable and can be delivered through a low-profile, 14-French, motorised delivery system. It is uniquely packaged with the valve fully pre-attached to the delivery system, which facilitates simple and rapid device pre...

Edwards Lifesciences Corporation has announced it has received U.S. 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.