Boston Scientific's Watchman heart implant shows improved safety profile in preliminary results

March 9, 2013 by Arezu Sarvestani

Boston Scientific hopes to reassure FDA regulators about the safety and efficacy of its Watchman stroke prevention implant with results from its PREVAIL study, the presentation for which was pulled from the lineup at the American College of Cardiology conference in San Francisco today.

Boston Scientific's Watchman device illustration

Boston Scientific (NYSE:BSX) today unveiled new results from a clinical trial of its Watchman stroke prevention device, reporting that the cardiac implant met 2 of 3 co-primary endpoints for safety and effectiveness compared with drug therapy.

The company's PREVAIL trial achieved its 2 safety endpoints, but researchers found no differences in rates of stroke, systemic embolism and cardiovascular or unexplained death at 18 months between patients who received the Watchman device and those who were treated with warfarin, a blood thinner.

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The device had success in more success in demonstrating lowered rates of acute death or serious vascular complications related to the procedure in the 7 days following implantation, as well as low rates of ischemic stroke or systemic embolism more than 7 days and up to 18 months following implantation, Boston Scientific announced.

The results were unveiled in a late-breaking trial presentation at the American College of Cardiology conference in San Francisco.