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Boston Scientific Says PREVAIL Results Affirm Safety of Watchman LAA Anti-Stroke Device

Inexperienced users had similar results as experienced operators in the PREVAIL trial of Boston Scientific’s Watchman left-atrial appendage closure device. FDA asked the company to conduct the trial after results of the PROTECT AF trial left doubts about the device’s safety and steep learning curve.

Boston Scientific Corp.believes the results from the PREVAIL

trial are enough to finally secure FDA approval for the Watchman left-atrial appendage closure device to prevent stroke in patients with atrial fibrillation, but skepticism about the device remains...

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