Through the catheter, the physician delivers the Amulet device to the left atrial appendage. A small hole is made in the wall between the two upper chambers of the heart so that the catheter can pass through to reach the left atrial appendage. How does it work?Ī physician inserts the delivery catheter into a blood vessel (vein) in the groin and advances it to reach the right upper chamber of the heart (right atrium). The device is made of a Nitinol (nickel-titanium) mesh with polyester fabric cover. The device is intended to prevent blood clots formed in the LAA from entering the bloodstream and potentially causing a stroke. The Amplatzer Amulet Left Atrial Appendage Occluder (LAAO) is a permanent implant that is placed in the patient’s left atrial appendage (LAA), which is a pouch-like part of the heart. Product Name: Amplatzer Amulet Left Atrial Appendage OccluderĪddress: 5050 Nathan Lane North, Plymouth, MN 55442, USAĪpproval 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.
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