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Testimony Before FDA’s Circulatory System Devices Panel Regarding the Abbott Vascular MitraClip Clip Delivery System

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Public Citizen’s Health Research Group strongly opposes the Food and Drug Administration’s (FDA) approval of the MitraClip Clip Delivery System (MitraClip) in high-risk patients due to a lack of evidence that the device’s benefits outweigh its risks, not limited to bleeding, cardiac arrest, and death.