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

View as PDF.

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.