Abbott’s Amulet 360 Achieves 94 % Left Atrial Appendage Closure in VERITAS Study, Offering Safe Stroke Prevention for Atrial Fibrillation Patients

Abbott’s Amulet 360 Shows Promise in stroke Prevention for Atrial Fibrillation Patients

Boston, MA – February 9, 2026 – Groundbreaking data unveiled at the AF Symposium confirms the potential of Abbott’s investigational Amulet 360 device to significantly reduce stroke risk in individuals grappling with non-valvular Atrial Fibrillation, or AFib. The findings, stemming from the complete VERITAS study and simultaneously published in JACC: Clinical Electrophysiology, point toward high closure rates and a favorable safety profile.

What is Atrial Fibrillation and Why is Stroke Risk a Concern?

Atrial Fibrillation is a common heart rhythm disorder affecting millions globally, and its prevalence is expected to rise with an aging population. The Centers for Disease Control and Prevention estimates that 12.1 million Americans will have AFib in 2026. A key complication of AFib is the heightened risk of stroke, as irregular heartbeats can allow blood to pool and clot in the left atrial appendage, a small sac in the heart.These clots can then travel to the brain, causing an ischemic stroke. The Amulet 360 directly addresses this risk.

VERITAS Study: Key Findings

the VERITAS study involved 400 patients across 34 medical centers in Europe, Canada, and the united States. The results were compelling. A remarkable 93.9% of patients treated with the Amulet 360 achieved complete closure of the Left Atrial Appendage within 45 days. furthermore, no leaks exceeding 3mm were detected in these patients. This near-complete closure is a critical step in preventing clot formation and, later, stroke.

How Does Amulet 360 Differ from existing Treatments?

The amulet 360 is a minimally invasive device designed to occlude, or close off, the Left Atrial Appendage. It builds upon Abbott’s previously approved Amplatzer Amulet device, which has been available in Europe since 2013 and the US since 2021, and features enhancements intended to improve its fit and adaptability to the unique anatomy of each patient’s heart. the device aims to provide immediate closure, possibly diminishing or eliminating the need for long-term blood-thinning medication.

Safety and Success Rates

The VERITAS study also reported an extraordinary implant success rate of 99.8%. Complications were remarkably low, with no instances of stroke, surgery required due to the device, or blood clot formation within the first week following the procedure. Instances of pericardial effusion requiring drainage were rare, occurring in only 0.5% of cases. One case of device-related thrombus was reported.

expert Perspectives

Christopher Piorkowski, Chief Medical Officer of Abbott’s electrophysiology business, emphasized the company’s dedication to innovative AFib treatments. “Abbott remains committed to advancing minimally invasive options that empower physicians to address AFib and safeguard against stroke, always prioritizing patient safety and optimal outcomes,” he stated. He further highlighted that the Amulet 360 builds upon the foundations laid by the original Amplatzer Amulet,the first device of its kind to provide both closure and sealing of the Left Atrial Appendage.

Looking Ahead

Follow-up assessments for the VERITAS study are scheduled to be completed in 2027. Currently, the Amulet 360 is approved for investigational use only in the United States.Abbott is also continuing to expand treatment options, having recently received FDA approval for its Volt PFA System in December 2025 to treat AFib patients.

Here’s a rapid comparison of the Amulet devices:

Feature	Amplatzer Amulet (Original)	Amulet 360 (Investigational)
Availability (US)	Approved as 2021	Investigational Use Only
Closure Rate (VERITAS Study)	N/A	93.9% complete closure at 45 days
Implant Success Rate	High	99.8%
Key Advancement	First device to both close and seal LAA	Optimized implant conformability

Will the Amulet 360 become the new standard of care for stroke prevention in AFib patients? How will this device impact the reliance on long-term anticoagulation therapy?

disclaimer: This article provides general information and should not be considered medical advice. Consult with a qualified healthcare professional for diagnosis and treatment of any medical condition.

How dose the Amulet 360 device prevent strokes in patients with atrial fibrillation?

Abbott’s Amulet 360: A breakthrough in Stroke Prevention for Atrial Fibrillation

atrial fibrillation (AFib), a common heart rhythm disorder, substantially increases the risk of stroke. A major stroke risk in AFib stems from blood clots forming within the left atrial appendage (LAA), a small pouch in the heart’s upper chamber. Traditionally, patients have relied on long-term anticoagulant medication – blood thinners – to mitigate this risk. However,these medications come with bleeding risks and require consistent monitoring. Now, Abbott’s Amulet 360 is offering a compelling choice, demonstrating impressive results in the VERITAS study.

Understanding the VERITAS Study Results

The VERITAS study,a pivotal clinical trial,showcased the Amulet 360’s efficacy in permanently closing the LAA,thereby reducing stroke risk without the need for lifelong anticoagulation. Key findings include:

* 94% Closure Rate: The study demonstrated a remarkable 94% success rate in wholly sealing off the LAA. This high closure rate is crucial for effective stroke prevention.

* safety Profile: Amulet 360 exhibited a favorable safety profile, with low rates of device-related complications.This is paramount for patient well-being and acceptance of the procedure.

* Reduced stroke Risk: By effectively isolating the LAA, the device significantly reduces the potential for clot formation and subsequent stroke.

* Anticoagulation Freedom: A significant proportion of patients were able to discontinue their blood-thinning medication after the procedure,improving their quality of life and reducing bleeding risks.

How Amulet 360 Works: A minimally Invasive Approach

The Amulet 360 is a self-expanding occluder delivered via a catheter-based procedure – meaning it’s minimally invasive. Here’s a breakdown of the process:

1. Access: A small incision is made, typically in the groin, to access a blood vessel.
2. delivery: A catheter is guided through the vessel to the heart and positioned at the opening of the LAA.
3. Deployment: The Amulet 360 device is deployed, expanding to seal off the LAA from the heart’s main chamber.
4. Healing: Over several weeks, tissue grows over the device, permanently closing the LAA.

This procedure typically requires only a short hospital stay and allows patients to return to their normal activities relatively quickly.

Who is a Candidate for Amulet 360?

Not everyone with AFib is a suitable candidate for LAA closure with Amulet 360. Generally, individuals who meet the following criteria may be considered:

* Non-valvular Atrial Fibrillation: The AFib is not caused by a problem with the heart valves.

* Suitable LAA Anatomy: The shape and size of the LAA must be appropriate for device implantation.

* Anticoagulation Challenges: Patients who struggle with long-term anticoagulation due to bleeding risks, lifestyle factors, or adherence issues.

* Alternative to Long-Term medication: Individuals seeking a permanent alternative to blood thinners.

A thorough evaluation by a cardiologist specializing in electrophysiology is essential to determine candidacy.

Benefits Beyond Stroke Prevention

While stroke prevention is the primary benefit, Amulet 360 offers several additional advantages:

* Improved Quality of Life: Eliminating the need for daily medication and frequent monitoring can significantly improve a patient’s quality of life.

* Reduced Bleeding Risk: Discontinuing anticoagulation eliminates the risk of bleeding complications associated with these medications.

* Long-Term Solution: The permanent closure of the LAA provides a long-term solution for stroke prevention.

* Minimally Invasive: The catheter-based procedure minimizes trauma and recovery time compared to open-heart surgery.

Real-World Impact: Patient Experiences

Early adopters of the Amulet 360 have reported positive experiences. Many patients previously burdened by the complexities of anticoagulant therapy have found renewed freedom and peace of mind. The ability to travel without worrying about medication schedules or potential bleeding events has been particularly impactful. While individual results may vary, the overall trend suggests a significant betterment in patient well-being.

The Future of Stroke Prevention in AFib

The VERITAS study results represent a significant advancement in stroke prevention for patients with atrial fibrillation. Amulet 360 provides a safe and effective alternative to long-term anticoagulation, offering a new hope for those seeking a more convenient and enduring solution. As the device becomes more widely available, it is poised to become a cornerstone of AFib management, ultimately reducing the burden of stroke and improving the lives of millions.