FDA approves LAA occlusion device for treatment of AF in patients at high risk for stroke
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Abbott announced the FDA approval of its left atrial appendage occlusion device for the treatment of atrial fibrillation in patients at risk for ischemic stroke.
According to a company press release, the device (Amplatzer Amulet) offers immediate left atrial appendage (LAA) closure, reducing risk for stroke and eliminating the need for blood-thinning medication.
According to the release, the device uses “dual-seal technology” to immediately seal the LAA. Additionally, the device has a wide range of occluder sizes and is recapturable and repositionable to ensure optimal placement.
“Amulet’s unique dual-seal approach has made it the No. 1 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 the structural heart division at Abbott, said in the release. “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.”
The FDA approval is supported by findings from the Amulet IDE trial, which will be presented at the virtual European Society of Cardiology 2021 Congress on Aug. 30.
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