FDA Advisory Committee votes a qualified yes for Watchman LAAC device for Stroke Prevention - Boston Scientific

After reviewing updated data and analysis for the Boston Scientific Corporation Watchman Left Atrial Appendage Closure (LAAC) Device, for Stroke Prevention, the FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee voted in favour of the Device. By a vote of 6 to 5 (with 1 abstention) the Panel concluded that the benefits of the Watchman Device outweigh the potential risks. Furthermore, the Panel voted that there is reasonable assurance that the Device is safe (12 yes to 0 no). On the question of reasonable assurance of effectiveness, the Panel vote was unfavourable (6 yes to 7 no).

The Panel provided substantial input and guidance related to the proposed Indications for Use and target patient population. There was widespread agreement among the Panel members that the Device provides a much needed alternative to long-term anticoagulation for some patients. While not bound by this vote, the FDA takes Advisory Panel comments and recommendations into account when reviewing the Watchman Device application. The company is committed to working with the FDA to address the Panel's comments