Abbott Receives CE Mark for Next-Generation Amulet 360 LAA Occluder
Abbott has received CE Mark for the Amulet 360 Left Atrial Appendage (LAA) Occluder, a next-generation device designed to reduce the risk of stroke in patients with non-valvular atrial fibrillation. Following approval, the first European cases using Amulet 360 were completed by Prof. Boris Schmidt at Cardiovascular Clinic Bethanien in Frankfurt, Prof. Ingo Eitel at the University Heart Center in Lubeck, and Prof. Jens Erik Nielsen-Kudsk at Aarhus University Hospital. The company will further expand use of the device across European countries in the coming weeks.
The left atrial appendage is a small, structurally complex pouch attached to the upper left chamber of the heart and the most common site for blood clot formation in people with AFib. For patients who are unable to take blood-thinning medication long-term, physicians may opt for closure of the LAA through a minimally invasive procedure using devices like Amulet 360 to seal off the LAA entirely and reduce stroke risk. The device is made of two primary components: a redesigned lobe that is softer and more conformable with smaller anchors to secure it in the LAA, and an outer disk that provides a second sealing layer. Together, the lobe and disk are designed to prevent blood clots and reduce stroke risk.
CE Mark for Amulet 360 was supported by insights from the VERITAS Study, which included 400 patients at more than 30 hospitals across the United States, Canada, and Europe. The 45-day results showed clinically meaningful closure rates and device safety, with successful implantation in 99.8% of patients, no reported patient complications such as additional surgery, strokes, or blood clots within the first seven days after implantation, and 93.9% of patients achieving complete closure of the LAA by 45 days with zero leaks greater than 3mm.
The CE Mark approval of Amulet 360 further expands Abbott’s portfolio of technologies designed to help physicians treat patients with cardiac arrhythmias. It is the company’s fourth major electrophysiology approval in just over a year, following U.S. and European approvals for the Volt PFA System in 2025 and European approval of TactiFlex Duo earlier this year. Amulet 360 is part of Abbott’s holistic portfolio of technologies designed to diagnose and treat AFib and reduce the risk of stroke. The device is approved for investigational use only in the United States.
Xavier Freixa, M.D., Ph.D., at Hospital Clínic de Barcelona, Spain, said with Amulet 360, doctors can help protect more people with AFib from stroke by confidently closing the left atrial appendage. Freixa noted that 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 proven legacy of the company’s unique dual-seal design seen in the first-generation LAA occluder, which has helped many people with AFib reduce their risk of stroke without long-term blood thinners. Piorkowski noted that as the latest addition to Abbott’s growing portfolio of stroke prevention technologies, Amulet 360 reflects the company’s commitment to advancing treatment options and improving outcomes for patients around the world.
