Amulet 360 Left Atrial Appendage Occluder Receives CE Mark for Stroke Prevention in Patients With Non-Valvular Atrial Fibrillation – Abbott

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.

Design updates improve closure and ease of use

Amulet 360 is made of two primary components. The device’s redesigned body, called a lobe, is softer and more conformable than Abbott’s previous-generation LAA occluder to help doctors treat more people with different types of LAA shapes. Amulet 360’s lobe has smaller anchors than the previous version to secure it in the LAA. The implant’s outer disk is a second sealing layer to help close off the LAA. Together, the lobe and disk are designed to help prevent blood clots and reduce the risk of stroke.

“With Amulet 360, doctors can help protect more people with AFib from stroke by confidently closing the left atrial appendage. 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.” – Xavier Freixa, M.D., Ph.D., at Hospital Clínic de Barcelona, Spain, and a globally recognized interventional cardiologist.

Strong clinical data supports Amulet 360

CE Mark for Amulet 360 was supported by insights from the VERITAS Study, which included 400 patients at more than 30 hospitals across the U.S., Canada and Europe. The study’s 45-day results – originally presented in a late-breaking session at the AF Symposium in Boston and simultaneously published in JACC: Clinical Electrophysiology earlier this year – showed clinically meaningful closure rates and device safety, including1:

• Favorable outcomes. The device was successfully implanted in 99.8% of patients.
• Positive safety profile. Amulet 360 met early safety benchmarks, including no reported patient complications such as additional surgery, strokes, or blood clots within the first seven days after implantation.
• Clinically relevant closure. A majority (93.9%) of patients implanted with the Amulet 360 achieved complete closure of the LAA by 45 days with zero leaks greater than 3 mm.

“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. 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.” – Christopher Piorkowski, M.D., chief medical officer of Abbott’s electrophysiology business.

Advancing Abbott’s growing portfolio of stroke prevention technologies

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 US and European approvals for the Volt  PFA System in 2025 and the European approval of TactiFlex  Duo earlier this year.