This is a brief overview of information related to FDA’s approval to market this product. 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.
Product Name: Amplatzer Amulet Left Atrial Appendage Occluder
PMA Applicant: Abbott Medical
Address: 5050 Nathan Lane North, Plymouth, MN 55442, USA
Approval Date: August 14, 2021
Approval Letter: Approval Order
What is it?
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. The device is intended to prevent blood clots formed in the LAA from entering the bloodstream and potentially causing a stroke. The device is made of a Nitinol (nickel-titanium) mesh with polyester fabric cover.
How does it work?
A 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). 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. Through the catheter, the physician delivers the Amulet device to the left atrial appendage. When the device is positioned properly in the appendage, it covers the opening of the appendage. Over time, a thin layer of tissue will grow over the surface of the Amulet device. This keeps any blood clots in the left atrial appendage from entering the bloodstream.
When is it used?
The Amplatzer Amulet Left Atrial Appendage Occluder is used in patients who have nonvalvular atrial fibrillation (atrial fibrillation that is not related to heart valve disease). In atrial fibrillation, the two upper chambers of the heart (right and left atria) no longer contract normally. As a result, the blood flow within the atria can be slower than normal. This change in blood flow may cause blood clots to form, especially in the left atrial appendage. The blood clots that form in the left atrial appendage can break loose, travel through the bloodstream, and block a blood vessel in the brain. If this occurs, the part of the brain that is supplied by that blood vessel can become permanently damaged within minutes. This type of brain damage is known as a stroke.
To reduce the chance that blood clots form, atrial fibrillation patients who are at increased risk for stroke are treated with blood-thinning medications called anticoagulants. Most patients can safely take these medications for years without serious side effects. However, some patients find that anticoagulants can be difficult to tolerate or because they increase the risk of bleeding problems. For those patients who have non-valvular atrial fibrillation, are at increased risk for stroke, are suitable for short-term anticoagulation therapy (blood thinning medication) but have an appropriate reason not to take anticoagulation therapy, using the Amulet device to close off the left atrial appendage from the bloodstream may be a reasonable option.
What will it accomplish?
The Amplatzer Amulet Left Atrial Appendage Occluder device is intended to prevent blood clots that form in the left atrial appendage from entering the bloodstream and causing a stroke. In a clinical study of 1,878 patients, about 80% of patients stopped anticoagulation medication after a successful procedure. After 18 months, only 2.8% of patients with the device experienced a stroke or other serious artery blockage issue from a blood clot.
When should it not be used?
The Amplatzer Amulet Left Atrial Appendage (LAA) Occluder should not be used in patients:
- Who have a blood clot in their heart
- Who have an active blood infection
- Where placing the device would impact the how the heart works