The new artificial valve is then expanded by a balloon and anchors to the previously implanted prosthetic ring around the mitral valve. The catheter is pushed through the blood vessels until it reaches the failing mitral valve.

The doctor then moves the catheter with the mounted valve through the femoral vein in the leg. The doctor compresses the SAPIEN 3 or SAPIEN 3 Ultra THV and places it on the end of a tube-like device called a balloon catheter. It was also approved for the replacement of a failing (narrowed, leaky, or both) previously implanted surgical biological aortic or mitral valve, or transcatheter aortic valve in patients who are too high risk for open-heart surgery. The Edwards SAPIEN 3 and SAPIEN 3 Ultra THV System was previously approved for the treatment of severe aortic stenosis (narrowing of the aortic valve) of the patient’s own heart valve. This current approval expands the use of this device to include using it to replace a failing mitral valve in patients who are too high risk for open-heart surgery when the valve has already been repaired with an artificial (prosthetic) ring. The SAPIEN 3 Ultra valve is a modified version of the SAPIEN 3 valve. The valve is made of cow tissue attached to a balloon-expandable, cobalt-chromium frame for support. The Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve (THV) System is a catheter-based artificial heart valve system designed to replace a diseased heart valve without open-heart surgery. Product Name: Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve SystemĪddress: One Edwards Way, Irvine, CA 92614Īpproval Letter: Approval Order What is it? See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. This is a brief overview of information related to FDA’s approval to market this product.

Ultra balloon