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More Data Challenges For Boston Sci’s Watchman In Lead-Up To Latest Panel

This article was originally published in The Gray Sheet

Executive Summary

Boston Scientific’s Watchman left-atrial appendage occluder for reducing stroke risk in patients at risk for thromboembolism missed both co-primary efficacy endpoints in the latest follow-up data from the PREVAIL study, but at least one analyst believes it still has a good chance of earning another endorsement from an FDA advisory panel in October. And metaanalysis data offered more support.

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Another Advisory Panel For Watchman Yields Another Mixed Result

The market prospects for Boston Scientific’s Watchman left-atrial appendage closure device for stroke remain uncertain following a narrow vote in favor of the device’s risk-benefit profile by FDA’s Circulatory System Devices Advisory Panel even though a majority of the panel did not believe the clinical data proved the device is effective.

Boston Scientific’s Watchman LAA Closer Returns To Advisory Panel

The FDA Circulatory System Devices Advisory Panel will review Boston Scientific Corp.’s Watchman Left Atrial Appendage Closure Technology and, separately, make recommendations on a group of allograft heart valves at an Oct. 8-9 panel meeting in Gaithersburg, Md.

Third Panel’s The Charm For Watchman? More Delays For Boston Sci’s Stroke Device

FDA has requested that a PMA for Boston Scientific’s Watchman left atrial appendage closure device for stroke-prevention be subject to another advisory panel meeting -- the third since 2009 -- which will delay the launch to, at earliest, the first half of 2015, the company says.

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