Advisory Panel Endorses Boston Scientific’s Watchman Left Atrial Appendage Closure Device
This article was originally published in The Gray Sheet
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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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.
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.
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.