The company presented data highlighting Amplatzer Amulet’s benefits in treating people with AFib at an increased risk of stroke. According to a news release, new five-year data demonstrates that the technology helps more patients avoid long-term use of blood-thinning medication compared to the Watchman device — an earlier generation of Boston Scientific’s own LAA closure device platform.
Findings provide insights into the long-term benefits of Amplatzer Amulet, Abbott said. The company said it highlights the device’s success in key factors, such as long-lasting outcomes, effective LAA closure and a reduced need for blood-thinning medication. These constitute critical considerations for physicians and patients when choosing an LAA closure approach.
Investigators presented findings at the American Heart Association’s Scientific Sessions 2024 in Chicago. They simultaneously published results in the Journal of the American College of Cardiology.
The Amplatzer Amulet trial news comes days after competitor Boston Scientific reported three-year primary endpoint results from a clinical trial of its Watchman FLX device, which Boston Scientific said demonstrated superiority to anticoagulants.
Abbott’s Amulet IDE trial evaluated more than 1,800 patients, making it the largest, randomized LAA occlusion study to date comparing Amplatzer Amulet head-to-head with Watchman, according to Abbott.
“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,” said Dr. Dhanunjaya Lakkireddy, who served as principal investigator for the Amulet IDE trial. “With the five-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.”
A look at the results from Abbott
Findings from the study included a significantly higher percentage of Amplatzer Amulet patients not using blood-thinner medication compared to Watchman patients (94% vs. 90.9%).
Abbott reported a significantly lower number of fatal or disabling strokes with Amulet (22 vs. 39). Data also showed superior closure of the LAA with Amulet compared to Watchman (89.2% vs. 83.3%).
AFib disrupts the heart’s ability to effectively pump blood, potentially leading to blood clots in the LAA. If those clots reach the blood stream, they can travel to the brain and cause stroke. According to Abbott, devices like Amplatzer Amulet help seal off the LAA entirely, reducing the risk of stroke caused by AFib. Patients with AFib who can’t take blood-thinning medication long-term may receive occlusion or closure of the LAA.
Long-term medication to reduce the risk of stroke is often not a viable option for many patients because of side-effects like bleeding. Amulet offers a dual-seal design to effectively treat nearly all LAA structures and achieve permanent closure.
Amplatzer Amulet has approval in more than 80 countries, including the U.S., Canada, Australia and in Europe as well.
“For years, doctors and their patients only had one minimally invasive option to close the LAA,” said Sandra Lesenfants, SVP 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.”
