Finally reaching its destination after an extremely long and strange trip, Boston Scientific gained approval from the FDA today to market its Watchman Left Atrial Appendage Closure Device in the US. The device has been in development for well over a decade and had been turned down by the FDA on several occasions.
According to the company, the Watchman is indicated as an alternative to long-term warfarin 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. 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, the current standard of therapy. 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.
Two years ago the controversial PREVAIL trial was pulled from its featured presentation on the program of the annual meeting of the American College of Cardiology after the company prematurely distributed to investors a press release summarizing the results of the trial.
