Report From HRS: PROTECT AF Positive For Watchman

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

Four-year follow-up data from the PROTECT AF clinical trial were presented at Heart Rhythm 2013, the Heart Rhythm Society (HRS) meeting held in early May in Denver, CO, and the results appear to provide the boost needed to support US Food and Drug Administration (FDA) approval of Boston Scientific Corp.’s Watchman left atrial appendage (LAA) closure device for stroke prevention in atrial fibrillation (AF) patients.

The results showed, for the first time, that LAA closure with the Watchman was statistically superior to warfarin in terms of efficacy, with Watchman demonstrating a 40% reduction in a...

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