Abbott has gained FDA approval for its Amplatzer Amulet left atrial appendage (LAA) occluder to treat atrial fibrillation (AFib) patients at a high risk of stroke.
The device was designed to “completely and immediately” seal the LAA with no need to prescribe blood thinners after the procedure.
“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,” Michael Dale, senior vice president of Abbott’s structural heart business, said in a prepared statement.
“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,” added Dhanunjaya Lakkireddy, MD, a specialist at the Kansas City Heart Rhythm Institute at HCA Midwest Health with extended experience using the device. “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.”
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Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.