CE Mark Granted to Abbott’s Next-Generation Amulet 360 Device

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

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 Amulet 360’s use across Europe over the next several weeks.

The LAA is a small, structurally complex pouch attached to the heart’s upper left chamber (atrium). 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 AFib patients who cannot take blood-thinning medication long-term, physicians may opt for LAA closure through a minimally invasive procedure using devices like Abbott’s Amulet 360 to seal off the LAA entirely and reduce stroke risk.

The Amulet 360 is made of two primary components. The device’s redesigned body—the 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 stroke risk.

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

The 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 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, including:¹

• 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 LAA closure by 45 days with no leaks greater than 3 mm. 

“Amulet 360 builds on the proven legacy of our 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,” stated Christopher Piorkowski, M.D., chief medical officer of Abbott’s electrophysiology business. “As the latest addition to Abbott’s portfolio of stroke prevention technologies, Amulet 360 reflects our commitment to advancing treatment options and improving outcomes for patients around the world.”

The CE Mark approval of Amulet 360 further expands Abbott’s 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 the European approval of TactiFlex Duo earlier this year. 

Frequently Asked Questions

What is Amulet 360?
The Amulet 360 device is a minimally invasive treatment option with dual-seal technology that can adapt to the unique shape of a patient’s LAA to immediately close it, potentially eliminating the need for blood-thinning medication when clinically appropriate. The next-generation Amulet 360 is built upon Abbott’s Amplatzer Amulet LAA Occluder, which has been in use in Europe since 2013 and the United States since 2021.

What is atrial fibrillation?
Atrial fibrillation is the most common sustained cardiac arrhythmia (irregular heartbeat). It occurs when the heart’s upper chambers (atria) beat out of coordination with the lower chambers (ventricles) and contract rapidly and irregularly.

What is the left atrial appendage?
The left atrial appendage (LAA) is a small pocket (or recess) connected to the heart’s upper left chamber that, in people with AFib, can allow blood to pool and increase the likelihood of a clot forming and traveling to the brain to cause a stroke.

How does Amulet 360 reduce stroke risk?
Delivered through a vein in the leg, Amulet 360 closes the LAA to reduce stroke risk.

How does Amulet 360 fit into Abbott’s AFib treatments?
Amulet 360 is part of Abbott’s holistic technologies designed to diagnose and treat AFib, and ultimately, reduce stroke risk.

Doctors use cardiac ablation therapies such as Abbott’s TactiFlex Duo Ablation Catheter, Sensor Enabled, or Volt PFA System—all of which employ different types of specialized energy to safely stop the heart’s erratic signals that can trigger AFib. Abbott’s EnSite X EP System creates highly detailed three-dimensional maps of the heart to help doctors find and treat the source of an irregular heartbeat. Procedures designed to combine Abbott’s LAA closure device and treat AFib simultaneously are currently being investigated in Europe.

The Amulet 360 Left Atrial Appendage Occluder is approved for investigational use only in the United States.

Abbott’s technologies span the spectrum of healthcare, with businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Its 122,000 colleagues serve people in more than 160 countries.

Reference
¹ Nair D. Early outcomes with a next-generation dual-seal device for left atrial appendage closure: Results from the VERITAS Amulet 360 Pivotal Study [Late Breaking Presentation]. Presented at: AF Symposium; February 6, 2026; Boston, MA, USA.