Abbott has received CE Mark approval for its Amulet 360 Left Atrial Appendage (LAA) Occluder, a next-generation medical device designed to reduce the risk of stroke in patients with non-valvular atrial fibrillation (AFib).

Following the approval, the first European procedures using Amulet 360 were performed by Prof. Boris Schmidt at Cardiovascular Clinic Bethanien in Frankfurt, Germany; Prof. Ingo Eitel at the University Heart Centre in Lubeck, Germany; and Prof. Jens Erik Nielsen-Kudsk at Aarhus University Hospital in Aarhus, Denmark. Abbott plans to expand availability of the device across additional European countries in the coming weeks.

The LAA is a small pouch connected to the upper-left chamber of the heart and is a common site for blood clot formation in people with AFib. These clots can potentially travel to the brain and cause a stroke. For patients who cannot take blood-thinning medication over the long term, physicians may use minimally invasive LAA closure procedures to seal the appendage and reduce stroke risk.

Amulet 360 features a redesigned two-component structure comprising a softer, more conformable lobe and an outer sealing disk. The redesigned lobe is intended to accommodate a wider range of LAA anatomies, while smaller anchors help secure the device within the appendage. The outer disk provides an additional sealing layer designed to prevent blood from entering the LAA.

According to Abbott, the device’s design builds on the company’s existing dual-seal approach while providing greater flexibility for physicians treating patients with different LAA shapes.

The CE Mark was supported by findings from the VERITAS study, which enrolled 400 patients across more than 30 hospitals in the US, Canada and Europe. The 45-day results demonstrated high implantation success and a favourable early safety profile.

The device was successfully implanted in 99.8 percent of patients in the study. Abbott reported that Amulet 360 met early safety benchmarks, with no reported patient complications involving additional surgery, stroke or blood clots during the first seven days following implantation.

At 45 days, 93.9 percent of patients achieved complete LAA closure with no leaks greater than 3 mm, according to the study results.

Xavier Freixa, M.D., Ph.D., interventional cardiologist at Hospital Clínic de Barcelona, Spain, said, “By helping doctors treat a wider range of anatomies, this next-generation device has the potential to improve outcomes and help more people benefit from stroke prevention across Europe.” 

Christopher Piorkowski, M.D., Chief Medical Officer of Abbott’s electrophysiology business, said Amulet 360 builds on the company’s dual-seal technology and expands its portfolio of stroke-prevention solutions for people with AFib.

The CE Mark approval further strengthens Abbott’s electrophysiology portfolio and represents the company’s fourth major electrophysiology approval in just over a year. It follows US and European approvals for the Volt PFA System in 2025 and European approval of TactiFlex Duo earlier this year.

The approval adds another technology to Abbott’s cardiovascular portfolio aimed at expanding treatment options for patients with cardiac arrhythmias and supporting physicians in managing stroke risk associated with AFib.