June 18th, 2014
Yet Another Delay for Boston Scientific’s Watchman Device
Larry Husten, PHD
Boston Scientific hopes the third time will be the charm. The company disclosed on Tuesday yet another obstacle in the path to approval for its novel Watchman left atrial appendage closure device for the prevention of stroke in patients with atrial fibrillation. Although it has already been before two FDA advisory panels, the company said that it had been informed by the FDA that it will need to undergo yet another advisory panel before gaining approval. The news was announced by Boston Scientific’s chief financial officer at a Wells Fargo investor’s conference.
Watchman has already travelled a long and rocky road. In 2010, the FDA issued a complete response letter following the first advisory panel. Last year, a scandal broke out when the American College of Cardiology cancelled a prestigious late-breaking clinical trial presentation of the PREVAIL trial, after the company broke an embargo by giving study results to investors. Last December, the FDA’s Circulatory System Devices Panel voted 13-1 in favor of the device, but as I reported at the time, the lopsided vote did not provide a full indication of lingering concerns about the device by panel members. In particular, panel members repeatedly expressed concern about the potential for overuse of the device. They also had trouble interpreting the major clinical trials with the device.
A date has not been set for the third panel. The company now anticipates approval of Watchman in the first half of 2015.
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