Abbott’s Amulet 360 LAA Occluder Receives CE Mark Approval

August 28, 2026—Abbott announced it has received CE Mark approval for the Amulet 360 left atrial appendage (LAA) occluder, a next-generation device designed to reduce risk of stroke in patients with nonvalvular atrial fibrillation (AFib).

The first European cases using Amulet 360 after approval were completed in Germany and Denmark; the company will further expand the use of Amulet 360 across European countries in the coming weeks, noted Abbott.

As described in the company’s press release, Amulet 360 is composed of a redesigned lobe that is softer and more conformable than the company’s previous-generation LAA occluder to allow the treatment of more patients with different types of LAA shapes. The lobe has smaller anchors than the previous version to secure it in the LAA. Additionally, the implant’s outer disk is a second sealing layer to help close off the LAA.

“With Amulet 360, doctors can help protect more people with AFib from stroke by confidently closing the LAA,” commented Xavier Freixa, MD, in the company’s press release. “By helping doctors treat a wider range of anatomies, this next-generation device has the potential to improve outcomes and help more people benefit from stroke prevention across Europe.” Dr. Freixa is from Hospital Clínic de Barcelona in Barcelona, Spain.

According to the company, CE Mark approval for Amulet 360 was supported by findings from the 400-patient VERITAS study that was conducted at more than 30 hospitals across the United States, Canada, and Europe.

In February 2026, Abbott announced that 45-day results from the VERITAS study were presented in a late-breaking session at the AF Symposium and published in JACC: Clinical Electrophysiology. The findings showed clinically meaningful closure rates and device safety. In June, an analysis of 45-day data from VERITAS were presented at the New York Valves 2026 conference.