Oct. 9, 2013

FDA Should Not Approve Cardio Device with Unknown Risks

Testimony of Dr. Michael Carome, Director, Public Citizen’s Health Research Group

WASHINGTON, D.C. – Dr. Michael Carome, director of Public Citizen’s Health Research Group, today testified before the FDA’s Circulatory System Devices Panel convened to consider the premarket approval application for the CardioMEMS Champion HF Monitoring System, a permanently implanted medical device to be used for monitoring heart failure patients. Public Citizen strongly recommends that to protect public health, the FDA should not approve this device because the studies evaluating its effectiveness were seriously flawed. The testimony can be viewed at https://www.citizen.org/our-work/health-and-safety/articles/testimony-fdas-circulatory-system-devices-panel-premarket.