The Food and Drug Administration (FDA) has approved Abbott’s Amplatzer ™ Amulet ™ Left Atrial Appendage Occluder, a percutaneous transcatheter device designed to reduce the risk of thrombus embolization from the left atrial appendage in patients with non-valvular atrial fibrillation and increased atrial fibrillation risk of stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short-term anticoagulation therapy and have reasonable grounds for looking for a non-pharmacological alternative to oral anticoagulation, taking into account the safety and efficacy of the product.
With dual-seal technology, the Amulet device is designed to completely and immediately close the left atrial appendage in patients with atrial fibrillation, eliminating the need for antithrombotic medication. The approval is supported by data from the Amulet IDE study (ClinicalTrials.gov Identifier: NCT02879448), which compared the effectiveness and safety of the Amulet device with the WATCHMAN® device for occluding the left atrial appendage in patients with non-valvular atrial fibrillation. The results of the study will be presented at the 2021 Congress of the European Society of Cardiology (ESC) on August 30, 2021.
“The approval of Abbott’s Amulet Device provides clinicians with a treatment option that reduces the risk of stroke and eliminates the need for blood-thinning medication immediately after the procedure, which is incredibly valuable given the bleeding risks associated with these drugs,” said Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute at HCA Midwest Health who served as principal investigator for the study that led to FDA approval.
The Amulet device is contraindicated in patients with intracardiac thrombi, active endocarditis, or other infections that cause bacteremia and where device placement would affect intracardiac or intravascular structures.
- Abbott’s Amplatzer ™ Amulet ™ device is FDA approved for the treatment of patients with atrial fibrillation at risk of stroke. Press release. Abbott. Accessed August 16, 2021. https://www.prnewswire.com/news-releases/abbotts-amplatzer-amulet-device-approved-by-fda-to-treat-people-with-atrial-fibrillation-at-risk – of-stroke-301355384.html.
- Amplatzer ™ Amulet ™ Left Atrial Appearance Closure: Important Safety Information. Santa Clara, CA: Abbott; 2021.
This article originally appeared on MPR
Atrial fibrillation General cardiac stroke treatments