PROTECT AF Results Show Long-Term Efficacy Of Watchman LAA Closure Device
This article was originally published in The Gray Sheet
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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FDA’s Circulatory System Devices advisory panel voted 13-1 to recommend approval of the firm’s PMA for the Watchman device as an alternative to warfarin therapy for stroke prevention in atrial fibrillation patients for whom long-term anticoagulant therapy is too risky.
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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.