Testimony Before the FDA’s Circulatory System Devices Panel Regarding the the AngelMed Guardian System

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Public Citizen strongly opposes approval of the premarket approval application for the AngelMed Guardian System. The results of the single pivotal randomized, controlled trial for the device, the ALERTS study, fail to provide a reasonable assurance that the device is effective for the proposed indication, and the conduct of the study was marred by serious protocol violations and post hoc modifications. The device also has serious risks that are not justifiable given the lack of evidence of effectiveness.