Abbott's Amplatzer Amulet Device Gains FDA Approval for Atrial Fibrillation
Abbott has received the FDA’s approval for its Amplatzer Amulet left atrial appendage occluder for treatment of individuals with atrial fibrillation (AFib) at risk of ischemic stroke.
The amulet immediately closes the patient’s left atrial appendage — an area where blood clots can form in patients with AFib — reducing the risk of stroke. It also eliminates the need for blood-thinning medication.
The occluder earned a CE mark in 2013 and has since been approved for use in more than 80 countries.