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FDA OKs Abbott's Amplatzer Amulet Device To Treat Atrial Fibrillation - Quick Facts

Abbott Laboratories (ABT) announced Monday that the U.S. Food and Drug Administration (FDA) approved the company's Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation (AFib) who are at risk of ischemic stroke.

The device offers immediate closure of the left atrial appendage (LAA), an area where blood clots can form in people suffering from AFib, reducing their risk of stroke and immediately eliminating the need for blood-thinning medication.

The LAA is a small pouch connected to the upper left chamber of the heart. For people with AFib, the most common of the persistent arrhythmias or irregular heartbeats, the heart's ability to effectively pump blood can be disrupted, allowing blood to pool and collect in the LAA causing an increased risk for clotting.

If clots reach the blood stream, they can travel to the brain and cause a stroke. For patients with AFib who are unable to take blood-thinning medication long term, physicians may opt for occlusion (or closure) of the LAA through a minimally invasive procedure using devices like Abbott's Amulet to seal off the LAA entirely and reduce the risk of stroke.

Before this approval, the only minimally invasive option for LAA occlusion for U.S. physicians and their patients was a solution with a single component to seal the LAA that requires blood-thinning drugs to heal and additional patient monitoring to ensure closure.

In contrast, Abbott's Amulet uses dual-seal technology to completely and immediately seal the LAA and recipients do not need to use blood-thinning medication following the procedure.

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