March 14th, 2015
FDA Approves Watchman Left Atrial Appendage Closure Device for AF
The FDA has approved Boston Scientific’s long-delayed Watchman Left Atrial Appendage Closure Device. According to the company, the Watchman is indicated as an alternative to long-term warfarin therapy for the reduction of thromboembolism from the left atrial appendage in patients with non-valvular atrial fibrillation at increased risk for stroke and systemic embolism.
Although an alternative to warfarin, for patients to be eligible they must be “deemed by their physicians to be suitable for warfarin” and to have an “appropriate rationale” for preferring the device to warfarin.
Boston Scientific said the device will be available first at centers where it has been used in clinical studies. Availability will be more widespread as physicians are trained in its use.
The Watchman has a long and highly troubled history at the FDA. The FDA has postponed approval of the device on several occasions as it found numerous problems with the clinical trials exploring its use. Most recently, last October, the FDA’s Circulatory System Devices advisory panel gave the device an extremely cautious endorsement. They said the trials supporting the device, PROTECT AF and PREVAIL, clearly showed that Watchman was not equivalent to warfarin. But they also felt that the device should be made available to AF patients who were eligible for but did not want to take warfarin.