The Food and Drug Administration (FDA) has approved Abbott’s Amplatzer™ Amulet™ Left Atrial Appendage Occluder, a percutaneous transcatheter device, intended to reduce the risk of thrombus embolization from the left atrial appendage in patients who have nonvalvular atrial fibrillation and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable for short term anticoagulation therapy, and have appropriate rationale to seek a nonpharmacologic alternative to oral anticoagulation, taking into consideration the safety and effectiveness of the device.
Using dual-seal technology, the Amulet device is designed for complete immediate closure of the left atrial appendage in patients with atrial fibrillation, eliminating the need for antithrombotic drugs. The approval is supported by data from Amulet IDE trial (ClinicalTrials.gov Identifier: NCT02879448), which compared the efficacy and safety of the Amulet device to the WATCHMAN® left atrial appendage closure device in patients with nonvalvular atrial fibrillation. Findings from the trial will be presented at the European Society of Cardiology (ESC) 2021 Congress on August 30, 2021.
“The approval of Abbott’s Amulet device provides physicians 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 medicines,” 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 for patients with the presence of intracardiac thrombus, with active endocarditis or other infections producing bacteremia, and where placement of the device would interfere with any intracardiac or intravascular structures.
- Abbott’s Amplatzer™ Amulet™ Device approved by FDA to treat people with atrial fibrillation at risk of stroke. News 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 Appendage Occluder: important safety information. Santa Clara, CA: Abbott; 2021.