![]() The valve is made of cow tissue attached to a balloon-expandable, cobalt-chromium frame for support. What is it? The Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System with Edwards Commander Delivery System consists of a catheter-based artificial heart valve and accessories used to implant the valve without open-heart surgery. Product Name: Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery 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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