August 28, 2026- Abbott announced it has received CE Mark for the Amulet 360™ Left Atrial Appendage (LAA) Occluder, a next-generation device designed to reduce risk of stroke in patients with atrial fibrillation (AFib) not caused by a heart valve issue (non-valvular).
Following approval, the first European cases using Amulet 360 were completed by Prof. Boris Schmidt at the Cardiovascular Clinic Bethanien in Frankfurt, Germany; Prof. Ingo Eitel at the University Heart Center in Lubeck, Germany; and Prof. Jens Erik Nielsen-Kudsk at Aarhus University Hospital in Aarhus, Denmark. The company will further expand the use of Amulet 360 across European countries in the coming weeks.
The LAA is a small, structurally complex pouch attached to the upper left chamber (atrium) of the heart. It is the most common place for blood clots to form and can potentially lead to stroke for people with AFib, an irregular heartbeat in the heart’s upper chambers. For patients with AFib 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 Abbott’s Amulet 360 to seal off the LAA entirely and reduce the risk of stroke.