FDA approves Sapien Transcatheter Heart Valve(Edwards Lifesciences) for patients with inoperable Aortic Valve Disease

The FDA has approved the transfemoral delivery of the Edwards Sapien Transcatheter Aortic Heart Valve for the treatment of inoperable patients with severe symptomatic Aortic Valve Disease or Stenosis. This is the first US commercial approval for a transcatheter device enabling aortic valve replacement (TAVR) without the need for open-heart surgery. The safety and effectiveness of the Sapien Transcatheter Valve has been evaluated in the pivotal PARTNER trial which showed that In patients with severe aortic stenosis who were not suitable candidates for surgery, TAVR, as compared with standard therapy, significantly reduced the rates of death and cardiac symptoms, despite the higher incidence of major strokes and major vascular events. As part of this approval, the FDA has requested the implementation of two substantial post-approval studies. One will follow patients already enrolled in The PARTNER Trial, and the second study will track new US patients. The company anticipates the second study will be incorporated into a new national patient registry.