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    Society Testifies in Support of Limited FDA Approval of Watchman Device

    November 09, 2014

    Zoltan Turi, MD, MSCAI testified on behalf of SCAI on Wednesday to the FDA Circulatory System Devices Panel, recommending that the FDA approve the WATCHMAN left atrial appendage occluder "for patients with reasons to avoid chronic anticoagulation while mandating additional data collection and analysis to help establish best practices, enhance quality improvement, identify anomalies, and establish the causes of adverse events.”

    The panel voted unanimously (12-0) that the device is safe for the proposed indication, but were split on efficacy (6-6) with the chair breaking the tie with a "no" vote. On the question of risk/benefit six panelists voted "yes", five panelists voted "no" and one abstained.

    Read SCAI's Testimony to the Panel Regarding Watchman