Abbott's next-generation Amulet 360™ device receives CE Mark to treat people with atrial fibrillation at risk of stroke

Q: What did Abbott (ABT) announce about the Amulet 360 device on August 27, 2026?

Abbott announced that its Amulet 360 LAA Occluder received CE Mark to reduce stroke risk in people with non‑valvular atrial fibrillation. According to Abbott, initial clinical use has begun in Germany and Denmark, with broader European expansion planned in the coming weeks.

Q: How effective is Abbott’s Amulet 360 (ABT) in closing the left atrial appendage?

According to Abbott, the Amulet 360 achieved complete LAA closure in 93.9% of patients by 45 days, with no leaks greater than 3 mm. These results come from the 400‑patient VERITAS study conducted across more than 30 hospitals in the U.S., Canada and Europe.

Q: Is Abbott’s Amulet 360 stroke-prevention device available in the United States?

Amulet 360 is currently approved for investigational use only in the U.S., according to Abbott. The device has received CE Mark for use in Europe, where commercial expansion is planned, but it has not yet obtained full commercial approval in the United States.

Q: How does the Amulet 360 device from Abbott (ABT) help reduce stroke risk in AFib patients?

Amulet 360 reduces stroke risk by sealing the left atrial appendage, where clots often form in AFib patients. Delivered via a leg vein, the device’s dual-seal lobe and disk design aims to prevent clot migration, potentially reducing dependence on long‑term blood‑thinning medication.

Q: What design improvements distinguish Abbott’s Amulet 360 from its first-generation LAA occluder?

According to Abbott, Amulet 360 features a softer, more conformable lobe with smaller anchors and a dual‑seal disk to better adapt to varied LAA anatomies. These updates are intended to enhance closure performance, broaden treatable patient anatomies and support improved stroke‑prevention outcomes in non‑valvular AFib.

Rhea-AI Impact

(Low)

Rhea-AI Sentiment

(Neutral)

Rhea-AI Summary

Abbott (NYSE: ABT) announced that its next-generation Amulet 360™ Left Atrial Appendage (LAA) Occluder has received CE Mark for reducing stroke risk in people with non‑valvular atrial fibrillation who are at risk and may not tolerate long‑term blood thinners.

The minimally invasive device uses a redesigned, softer lobe with smaller anchors and an outer disk to improve conformity and dual-seal closure of the LAA. According to Abbott, CE Mark was supported by the 400‑patient VERITAS study, which showed a 99.8% successful implant rate, no reported major complications within seven days, and 93.9% complete LAA closure at 45 days (no leaks >3 mm). Initial cases have been performed in Germany and Denmark, with broader European rollout planned. Amulet 360 remains investigational only in the U.S. and expands Abbott’s electrophysiology and stroke‑prevention portfolio alongside Volt™ PFA, TactiFlex™ Duo and the EnSite™ X mapping system.

Positive

99.8% successful implant rate for Amulet 360 in 400‑patient VERITAS study
Early safety benchmarks met with no reported strokes, blood clots or additional surgery within seven days
93.9% of patients achieved complete LAA closure at 45 days with no leaks >3 mm
CE Mark enables commercial rollout across Europe for high‑risk non‑valvular AFib patients

Negative

None.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google

08/27/2026 - 09:00 AM

Amulet 360 helps seal the left atrial appendage (LAA) of a person's heart, reducing the need for blood-thinning medication
Amulet 360 builds upon Abbott's first-generation LAA device with design updates to enhance how the implant conforms to and seals the LAA to help reduce the risk of a stroke
Recent clinical trial data show Amulet 360 met benchmarks for safety and effectiveness

ABBOTT PARK, Ill., Aug. 27, 2026 /PRNewswire/ -- Abbott (NYSE: ABT), the global healthcare leader, announced today 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," said Xavier Freixa, M.D., Ph.D., 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."

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," said Christopher Piorkowski, M.D., chief medical officer of Abbott's electrophysiology business. "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."

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.

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 U.S. since 2021.

What is atrial fibrillation?
Atrial fibrillation (AFib) is the most common sustained cardiac arrhythmia (irregular heartbeat). It occurs when the upper chambers of the heart (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 upper left chamber of the heart 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 the risk of stroke.

How does Amulet 360 fit into Abbott's treatments for AFib?
Amulet 360 is part of Abbott's holistic portfolio of technologies designed to diagnosis and treat AFib, and ultimately, reduce the risk of stroke.

Where commercially available, doctors use cardiac ablation therapies such as Abbott's TactiFlex™ Duo Ablation Catheter, Sensor Enabled™, or Volt™ PFA System, which use 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 U.S.

For U.S. important safety information go to:

Volt™ PFA System,
https://www.cardiovascular.abbott/us/en/ep-clinical-evidence/volt-clinical-evidence.html

EnSite™ X EP System, https://www.cardiovascular.abbott/us/en/hcp/products/electrophysiology/mapping-systems/ensite-x.html

About Abbott:
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube.

_____________________________

¹Nair 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.

View original content:https://www.prnewswire.com/news-releases/abbotts-next-generation-amulet-360-device-receives-ce-mark-to-treat-people-with-atrial-fibrillation-at-risk-of-stroke-302861049.html

SOURCE Abbott

FAQ

What did Abbott (ABT) announce about the Amulet 360 device on August 27, 2026?

Abbott announced that its Amulet 360 LAA Occluder received CE Mark to reduce stroke risk in people with non‑valvular atrial fibrillation. According to Abbott, initial clinical use has begun in Germany and Denmark, with broader European expansion planned in the coming weeks.

How effective is Abbott’s Amulet 360 (ABT) in closing the left atrial appendage?

According to Abbott, the Amulet 360 achieved complete LAA closure in 93.9% of patients by 45 days, with no leaks greater than 3 mm. These results come from the 400‑patient VERITAS study conducted across more than 30 hospitals in the U.S., Canada and Europe.

What safety results were reported for Abbott’s Amulet 360 device in the VERITAS study?

Abbott reports that Amulet 360 met early safety benchmarks, with no additional surgery, strokes or blood clots within seven days after implantation. The VERITAS study included 400 patients, and the device was successfully implanted in 99.8% of cases at participating hospitals.

Is Abbott’s Amulet 360 stroke-prevention device available in the United States?

Amulet 360 is currently approved for investigational use only in the U.S., according to Abbott. The device has received CE Mark for use in Europe, where commercial expansion is planned, but it has not yet obtained full commercial approval in the United States.

How does the Amulet 360 device from Abbott (ABT) help reduce stroke risk in AFib patients?

Amulet 360 reduces stroke risk by sealing the left atrial appendage, where clots often form in AFib patients. Delivered via a leg vein, the device’s dual-seal lobe and disk design aims to prevent clot migration, potentially reducing dependence on long‑term blood‑thinning medication.

What design improvements distinguish Abbott’s Amulet 360 from its first-generation LAA occluder?

According to Abbott, Amulet 360 features a softer, more conformable lobe with smaller anchors and a dual‑seal disk to better adapt to varied LAA anatomies. These updates are intended to enhance closure performance, broaden treatable patient anatomies and support improved stroke‑prevention outcomes in non‑valvular AFib.