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The Watchman Saga — Closure at Last?

NEJM - Atrial fibrillation is a critical public health issue, and its clinical burden and related costs will only grow as the aging of the U.S. population increases its prevalence and the risk of resulting stroke and systemic embolism. Several investigators have tried to prevent complications of atrial fibrillation using medical devices designed to prevent embolization of clots formed in the left atrial appendage. Although such devices have been available for nearly a decade in Europe, they are not yet approved in the United States. Examination of the review conducted by the Food and Drug Administration (FDA) of one device for closure of the left atrial appendage provides insight into differences in medical-device regulation between the United States and the European Union (EU) and highlights the urgency of monitoring devices in a coordinated and rigorous manner.