The next-generation minimally invasive device is designed to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AFib) by helping seal the LAA of the patient’s heart.
Amulet 360 features a redesigned dual-seal technology that adapts to the shape of the patient’s LAA and closes the appendage, possibly eliminating the need for blood-thinning medication. The device is made of flexible, braided nitinol mesh.
The device’s remodeled lobe is softer and more conformable than Abbott’s previous-generation LAA device, Amplatzer Amulet. The revamped lobes enable physicians to treat patients with different types of LAA shapes, the company said. The new device’s lobes also have smaller anchors for better securement in the LAA.
The implant’s outer disk provides a second sealing layer to improve closure of the LAA by combining with the lobe to prevent blood clots and reduce stroke risk.
Related: Abbott reports strong outcomes for next-gen Amulet LAA occlusion device
“Amulet 360 builds on the proven legacy of our unique dual-seal design seen in the first-generation LAA occluder, which helped many people with AFib reduce their risk of stroke without the need for long-term blood thinners,” Abbott’s Electrophysiology business Chief Medical Officer Dr. Christopher Piorkowski said in a news release. “As the latest addition to Abbott’s growing portfolio of stroke prevention technologies, Amulet 360 reflects our commitment to advancing treatment options and improving outcomes for patients around the world.”
To support its CE Mark submission, Abbott conducted a 400-patient pivotal study to evaluate the safety and effectiveness of the next-gen device. The 45-day primary analysis results showed 94% of patients achieved complete LAA closure by the 45-day mark, with zero leaks greater than 3 mm.
Amulet 360 was also successfully implanted in 99.8% of patients. There were no reported complications such as strokes, blood clots, or additional surgeries within seven days following implantation, the company said.
After earning CE mark, the first European cases using Amulet 360 were completed in Germany and Denmark. Abbott plans to expand the new device’s use across Europe in the coming weeks. Amulet 360 is currently approved for investigational use in the US.
