Edwards Sapien 3 Valve Approved in Europe

January 27, 2014—Edwards Lifesciences (Irvine, CA) announced that it has received CE Mark approval of the Edwards Sapien 3 transcatheter aortic valve and that the company has initiated the European launch.

According to the company, the Sapien 3 valve has an outer skirt (a cuff of fabric surrounding the valve frame) that provides a seal to address paravalvular leak. Edwards stated that the effectiveness of this solution is supported by the limited clinical experience, detailed in two first-in-human feasibility studies, that demonstrated that significant paravalvular leak was eliminated during transcatheter aortic valve implantation.

The Sapien 3 valve can be delivered through a low-profile, 14-F expandable sheath (eSheath), which has shown a low rate of complications through early clinical experience. The valve can be implanted through multiple approaches: transfemoral, transapical, or transaortic. When implanted, the valve anchors in the aortic annulus.

In the United States, the Edwards Sapien 3 valve is an investigational device being studied in the PARTNER II trial and is not yet available for sale, advised the company.