The Amplatzer Amulet is a left atrial appendage occluder to reduce ischemic stroke risk for people with atrial fibrillation (AFib). The device is a small pouch connected to the upper left chamber of the heart.
AFib is the most common of the persistent arrhythmias or irregular heartbeats. It affects the heart’s ability to effectively pump blood and allows blood to pool and collect in the left atrial appendage to cause an increased risk for clotting. Clots that reach the bloodstream have the potential to travel to the brain and cause a stroke, according to Abbott.
“As the world’s population continues to age, we’re seeing a surge in atrial fibrillation cases, and with that comes increased risk of stroke,” said Dr. Dhanunjaya Lakkireddy, the principal investigator on the Amplatzer Amulet study, in a news release. “The approval of Abbott’s Amulet device provides physicians with a treatment option that reduces the risk of stroke and eliminates the need for blood-thinning medication immediately after the procedure, which is incredibly valuable given the bleeding risks associated with these medicines.”
Abbott Park, Ill.–based Abbott designed the device with a dual-seal technology to completely and immediately seal the left atrial appendage. Patients who receive the device do not need to use blood-thinning medication following the procedure. The device can also treat a broad range of anatomies, has a wide range of occluder sizes and is recapturable and repositionable, according to the company.
“Amulet’s unique dual-seal approach has made it the number one LAA closure product in Europe, so today’s device approval by the FDA is an important milestone in allowing us to bring this treatment option to American physicians and patients,” said Michael Dale, senior VP of Abbott’s structural heart business. “Consistent with our mission purpose, our minimally invasive Amulet procedure for reducing stroke risk in patients with atrial fibrillation will help people live better lives through better health.”