美国医疗科技：TCT周日要点——VERITAS数据支持雅培Amulet 360，EARLY TAVR经济学数据积极

Abbott released VERITAS (n=458) data that should support FDA approval of its next-generation Amulet 360 LAAO device (early 2027E). The global single-arm multi-center study met its primary and secondary endpoints, demonstrating: 1) all-cause mortality of 3.9%; 2) cardiovascular mortality of 1.9%; 3) major bleeding in 6.6% of patients, though most were not procedure-related bleeding; 4) ischemic stroke or systemic embolism of 1.8% (in a population with an annualized expected rate of 4-5%); 5) pericardial effusion requiring intervention of 0.9%; and 6) complete LAA closure (0 mm leak) of 96.3% by TEE. In sum, we see the data supporting FDA approval for Amulet 360 and providing a reasonable dataset for LAA devices. Compared with Boston Scientific's PINNACLE FLX (n=400): all-cause mortality 3.9% vs 6.4%; cardiovascular mortality 1.9% vs 4.2%; major bleeding 6.6% vs 8.2%; ischemic stroke or systemic embolism 1.8% vs 3.1%; pericardial effusion requiring intervention 0.9% vs 1.0%;