FDA Approves Abbott's Amplatzer Amulet for Atrial Fibrillation

Patrice Wendling

August 17, 2021

The US Food and Administration (FDA) has approved the Amplatzer Amulet left atrial appendage occluder (Abbott) to treat people with nonvalvular atrial fibrillation who are at increased risk for stroke and systemic embolism.

The Amulet and its competitor, Boston Scientific's Watchman, are minimally invasive devices used to close off the left atrial appendage (LAA), an area where blood clots tend to form in people with atrial fibrillation.

Amulet uses dual-seal technology to completely and immediately seal the LAA, the company says, whereas the other minimally invasive solution uses a single component to seal the LAA that requires blood-thinning drugs to heal and additional patient monitoring. The Amulet also has the widest range of occluder sizes on the market and is recapturable and repositionable to ensure optimal placement.

"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. 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," Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute at HCA Midwest Health, Overland Park, and principal investigator for the study that led to FDA approval, said in a news release from Abbott.

The FDA approval is supported by findings from the global Amulet IDE trial, a head-to-head comparison of the Amulet and Watchman devices in 1878 participants with nonvalvular atrial fibrillation. The results will be presented virtually on August 30 at the European Society of Cardiology 2021 Congress.

The Amplatzer Amulet received CE Mark designation in 2013 and is approved for use in more than 80 countries, including in Australia, Canada, and European countries.

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