Oct 13th 2021
FDA Approves Amulet LAAO Device Based Upon Amulet IDE Trial
The Amulet IDE study randomized 1878 patients to undergo LAAO with the Amulet device or the Watchman device. Amulet was non-inferior to Watchman with respect to both a safety endpoint (procedure complications, all-cause mortality, major bleeding at 1 year; 14.5% vs. 14.7%, p<0.001) and an efficacy effectiveness endpoint (ischemic stroke or systemic embolism at 18 months; 2.8% vs. 2.8%; p<0.001). Complete LAA occlusion was higher for the Amulet device (98.9% vs. 96.8%, p=0.003 for superiority). Most Amulet patients (75.7%) were treated with 6 months of aspirin plus clopidogrel, whereas most Watchman patients (82.0%) were treated with aspirin + warfarin for 45 days prior to deescalating to aspirin + clopidogrel. Based upon these study results the US Food and Drug Administration (FDA) approved the Amulet device for implantation with 6 months of aspirin + clopidogrel.