Abbott, a leader in the healthcare sector, revealed significant new findings concerning its Amplatzer Amulet Left Atrial Appendage (LAA) Occluder for individuals with atrial fibrillation (AFib) who face heightened stroke risk. Recent five-year research highlights that patients using Abbott’s Amplatzer Amulet can reduce reliance on blood-thinning medications more effectively compared to those using the Watchman device.
This information provides healthcare professionals with crucial insights into the extended benefits of the Amplatzer Amulet for stroke-prone AFib patients. Essential components such as enduring outcomes, efficient LAA closure, and decreased requirements for blood-thinning medications play a vital role for doctors and patients when considering LAA closure options.
Results of this study were unveiled at the American Heart Association’s Scientific Sessions 2024 in Chicago (November 16-18, 2024) and simultaneously published in the Journal of the American College of Cardiology.
Key observations from the Amplatzer Amulet IDE trial include:
The Amulet IDE trial, with over 1,800 participants, is the largest randomized, LAA occlusion study comparing Abbott’s Amplatzer Amulet LAA Occluder with Boston Scientific’s Watchman device. Five-year data from this international clinical trial revealed:
– A statistically higher rate of Amplatzer Amulet users were free from blood-thinning medication compared to Watchman users (94.0% vs. 90.9%). – There were significantly fewer fatal or disabling strokes among Amulet users (22 vs. 39). – The Amulet demonstrated a higher efficacy in closing the LAA compared to the Watchman (89.2% vs. 83.3%).
“By minimizing the need for blood thinners, which can lead to excessive bleeding and cause side effects like nausea or dizziness, physicians prioritize avoiding these medications after LAA closure,” explained Dhanunjaya Lakkireddy, M.D., from the Kansas City Heart Rhythm Institute at HCA Midwest Health, who was the principal investigator for the Amulet IDE trial. “The five-year findings from Abbott’s study enable doctors to confidently recommend the Amulet device for AFib patients, ensuring effective LAA closure and reduced stroke risk without long-term blood-thinning medication.”
AFib is a condition that disrupts the heart’s rhythm, potentially leading to blood clot formation in the LAA, a small pocket attached to the heart’s upper chamber. If these clots enter the bloodstream, they can reach the brain, leading to a stroke. While blood-thinning medications can lower this risk, not all patients can endure these drugs long-term. In such cases, doctors may opt for a minimally invasive procedure to seal off the LAA using solutions like Abbott’s Amplatzer Amulet, thereby diminishing stroke risk.
Blood-thinning medication is often not a sustainable option due to side effects like bleeding. For these patients, the Amulet device presents an innovative solution with its dual-seal design, capable of treating almost all LAA structures and securing permanent closure.
“Historically, there was only one minimally invasive choice for LAA closure,” shared Sandra Lesenfants, Abbott’s senior vice president for structural heart business. “The Amplatzer Amulet’s dual-seal technology offers complete and immediate LAA closure without needing post-procedural blood thinners. This data underscores the device’s safety and efficacy, helping individuals live risk-free from strokes.”
Since its CE Mark approval in 2013 and FDA approval in 2021, the Amplatzer Amulet LAA Occluder has been available across more than 80 countries, including key markets like Europe, the United States, Canada, and Australia.
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