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Another Advisory Panel For Watchman Yields Another Mixed Result

This article was originally published in The Gray Sheet

Executive Summary

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.

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LAA Closure Devices At The Tipping Point

Since the FDA approval of Boston Scientific Corp.'s WATCHMAN device in March, the US market for left atrial appendage closure devices has reached a tipping point. With first-to-market advantage in the US, and a four- to five-year lead on the competition in bringing a LAAC device to the US market, BSX is well positioned to gain a strong foothold in this potentially billion dollar plus market; however, several factors will dictate market adoption of these devices in the US, including reimbursement, clinical efficacy, cost and ease of use.

Boston Sci’s Watchman Stroke Device Finally Lands FDA Approval, With Favorable Labeling

Three separate FDA advisory panels examined the clinical data supporting the left-atrial appendage closure device and struggled to identify exactly which patients it benefits. But FDA has finally approved Watchman with an indication that analysts say will support meaningful market action for Boston Scientific. Reimbursement policies, however, remain a question mark.

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

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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