Abbott’s Amplatzer Amulet LAA Occluder in AFib Evaluated at 5 Years in IDE Trial

November 22, 2024—Abbott recently announced late-breaking data for the company’s Amplatzer Amulet left atrial appendage (LAA) occluder to treat patients with atrial fibrillation (AFib) who are at an increased risk of stroke.

The randomized investigational device exemption (IDE) trial compared the Amplatzer Amulet LAA occluder to the Watchman device (Boston Scientific) in avoiding long-term use of blood-thinning medication. The prospective, randomized global clinical trial comprises more than 1,800 patients.

The results from the Amulet IDE trial were presented at the American Heart Association’s Scientific Sessions 2024 held November 16-18 in Chicago, Illinois, and simultaneously published online by Dhanunjaya Lakkireddy, MD, et al in the Journal of the American College of Cardiology.

Dr. Lakkireddy, from the Kansas City Heart Rhythm Institute at HCA Midwest Health in Overland Park, Kansas, served as principal investigator for the Amulet IDE trial.

As outlined in Abbott’s press release, the 5-year data comparing patients treated with Amplatzer Amulet versus Watchman demonstrated the following:

• A statistically significant higher percentage using blood-thinner medication compared to Watchman patients (94.0% vs 90.9%)
• A statistically significant lower number of fatal or disabling strokes were experienced (22 vs 39)
• Statistically significant superior closure of the LAA (89.2% vs 83.3%)

“Because blood thinners may cause excessive bleeding and side effects like nausea or dizziness, we as physicians want to avoid these medications for our patients following an LAA closure procedure,” commented Dr. Lakkireddy in Abbott’s press release. “With the 5-year findings from Abbott’s Amulet IDE study, doctors can even more confidently offer AFib patients the minimally invasive Amulet device that not only closes the LAA and reduces their risk of stroke but can also keep them off blood-thinning medication long-term.”

According to Abbott, the study findings provide insights into the long-term benefits of the Amplatzer Amulet for patients at risk of stroke caused by AFib. The company noted that key considerations in choosing an LAA closure approach include long-lasting outcomes, effective LAA closure, and a reduced need for blood-thinning medication.

The company stated that the Amplatzer Amulet device features a dual-seal design that can effectively treat most LAA structures and achieve permanent closure.

Abbott noted that the Amplatzer Amulet LAA occluder has been approved for use in over 80 countries, including Europe, the United States, Canada, and Australia. The device received CE Mark approval in 2013 and FDA approval in 2021.