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...
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.