This canlead to life-threatening heart problems such as fainting, chest pain, irregular heart rhythm ( arrhythmia), heart failure or cardiac arrest. As the heart works harder to pump enough blood through a failing valve, it eventually weakens.
When is it used? The SAPIEN 3 and SAPIEN 3 Ultra THV are used in patients with a transcatheter aortic valve that has become narrowed, leaky, or both, and restricts blood flow through the valve. Once the new valve is in place, it functions the same as the old valve, opening and closing like a door to guide blood flow in the correct direction. The new artificial valve is then expanded by a balloon and anchors to the failed valve. The catheter is pushed through the blood vessels until it reaches the failing previously implanted transcatheter aortic valve. The doctor then moves the catheter with the mounted valve through the femoral artery in the leg or a small cut between the ribs. How does it work? 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. This current approval expands the indications to include the replacement of a failing (narrowed, leaky, or both) use previously implanted transcatheter aortic valve. It was also approved for the replacement of a failing (narrowed, leaky, or both) previously implanted surgical artificial aortic or mitral heart 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 of the patient’s own heart valve. 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. What is it? The Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve (THV) System each consists of a catheter-based artificial aortic heart valve and the accessories used to implant the valve without open-heart surgery. Product Name: Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve SystemĪddress: One Edwards Way, Irvine, CA 92614 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.
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