New Data Backs Abbott’s Amplatzer Amulet to Treat AFib with Stroke Risk

Abbott has unveiled late-breaking data for its Amplatzer Amulet left atrial appendage (LAA) occluder to treat patients with atrial fibrillation (AFib) at an increased stroke risk.

The Amulet device features a dual-seal design that can effectively treat nearly all LAA structures and achieve permanent closure, Abbott said. It’s been approved for use in over 80 countries, including in Europe, the U.S., Canada and Australia, since its initial CE mark approval in 2013 and FDA approval in 2021.

The five-year findings showed that Amplatzer Amulet helps more patients avoid long-term blood thinner use compared to Boston Scientific’s Watchman device, the company said. The results were presented at the American Heart Association’s Scientific Sessions 2024.

The Amplatzer Amulet investigational device exemption (IDE) trial compared the device to Watchman in a head-to-head study.

94% of Amplatzer Amulet patients weren’t using blood thinner medication compared to Watchman’s 90.9%. 22 fatal or disabling stokes were reported with Amplatzer Amulet vs. 39 with Watchman. Superior LAA closure was also found, with Amulet achieving 89.2% and Watchman achieving 83.3%.

“For years, doctors and their patients only had one minimally invasive option to close the LAA,” said Sandra Lesenfants, senior VP of Abbott’s structural heart business. “The Amplatzer Amulet redefined LAA closure by offering dual-seal technology that completely and immediately seals the LAA without requiring blood-thinning medication following the procedure. These data reinforce that the Amulet device is safe and effective, and also, importantly, that it’s helping people enjoy their lives and worry less about the risk of having a stroke.”