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

This article was originally published in The Gray Sheet

Executive Summary

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.

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Advisory Panel Endorses Boston Scientific’s Watchman Left Atrial Appendage Closure Device

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PROTECT AF Results Show Long-Term Efficacy Of Watchman LAA Closure Device

Boston Scientific is highlighting a secondary-endpoint analysis showing that the left-atrial appendage closure device reduced all-cause death by 34 percent. The company plans to submit a PMA for the device by the end of the second quarter.

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