Amulet is said to be the first and only minimally invasive treatment option to offer immediate closure of LAA, eliminating use of blood-thinning medication
Abbott headquarters. (Credit: Abbott.)
Abbott has obtained the US Food and Drug Administration (FDA) approval for its Amplatzer Amulet Left Atrial Appendage Occluder to treat atrial fibrillation (AFib) in patients who are at risk of ischemic stroke.
The device works by immediately closing the left atrial appendage (LAA), a small pouch connected to the upper left chamber of the heart.
In people with AFib, persistent arrhythmias (irregular heartbeats) can disrupt the heart’s ability to effectively pump blood, leading to the formation of blood clots in the LAA.
When the blood clots enter the bloodstream, may travel to the brain and cause a stroke.
By closing the LAA, the device reduces the patients’ risk of stroke and eliminates the immediate need for blood-thinning medication, said the healthcare company.
Abbott structural heart business senior vice president Michael Dale said: “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.
“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.”
Previously, a solution with a single component to seal the LAA was the only minimally invasive option for LAA occlusion in the US, which requires blood-thinning drugs to heal.
Abbott said that its Amulet leverages dual-seal technology to immediately seal the LAA, and does not require the use of blood-thinning medication after the procedure.
The device is designed to treat a wide range of anatomies, has the widest range of occluder sizes, and is recapturable and repositionable to ensure optimal placement.
Abbott’s Amplatzer Amulet LAA Occluder has been approved in more than 80 countries, including in Europe, Canada and Australia. It received CE Mark approval in 2013.
The FDA approval is supported by findings from the Amulet IDE trial, a large-scale head-to-head study that compared Amulet with alternative minimally invasive LAA occlusion device.
FDA approval study principal investigator Dhanunjaya Lakkireddy said: “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.
“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.”