Boston Scientific Says PREVAIL Results Affirm Safety of Watchman LAA Anti-Stroke Device
This article was originally published in The Gray Sheet
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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Boston Scientific’s recent acquisition of Bard Electrophysiology marks the tenth notable acquisition that it has made since 2010. Four of those deals come in cardiac rhythm management, including EP, which is among the fastest-growing device sectors and one that company executives see as a major contributor to future growth.
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.