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# Abbott PMA Approved for Amplatzer Amulet
- URL: https://www.fdaweb.com/abbott-pma-approved-for-amplatzer-amulet/
- Published: 2021-08-16T12:00:00.000Z
- Updated: 2026-09-14T17:10:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149937

FDA has approved an Abbott PMA for the Amplatzer Amulet Left Atrial Appendage Occluder to treat people with atrial fibrillation (AFib) who are at risk of ischemic stroke. The device is intended to close the left atrial appendage (LAA), which is where blood clots can form in people suffering from AFib, the company says. By performing the closure, it reduces the risk of stroke and eliminates the need for blood-thinners, it says.

The Amulet is currently approved in more than 80 countries. FDA approval was supported by findings from the Amulet IDE trial, a large-scale randomized head-to-head study comparing Amulet with an alternative minimally invasive LAA occlusion device, Abbott says. Data from the study which will be virtually presented 8/30 at the European Society of Cardiology 2021 Congress.