Overview of the 2011 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting on the CardioMEMS Champion Heart Failure Monitoring System.
The CardioMEMS Champion Heart Failure Monitoring System (CardioMEMS, Atlanta, Georgia) is a permanently implantable pressure measurement system designed to wirelessly measure and monitor pulmonary artery (PA) pressure and heart rate in heart failure (HF) patients to guide ambulatory HF management and to reduce HF hospital stays. On December 8, 2011, the Food and Drug Administration (FDA) Circulatory System Device Panel reviewed the CardioMEMS Champion HF Monitoring System premarket approval (PMA) application. The majority of Panel members agreed that that the discussed monitoring system is safe for use in the indicated patient population. However, new information reported by the FDA with regard to preferential support in management of patients in the treatment group raised concerns among the Panel members with regard to potential bias in analyzing the efficacy of the device itself. Additionally, Panel members raised concerns with regard to the efficacy of the device in certain patient subpopulations. Hence, most Panel members decided that there was not reasonable assurance that the discussed monitoring system is effective. This summary aims to describe the discussions and recommendations made during this meeting.
Interventional Cardiology, MedStar Washington Hospital Center, Washington DC 20010, USA.
Joshua P
JP
Loh
Israel M
IM
Barbash
Ron
R
Waksman
D026683:Advisory Committees; D018660:Blood Pressure Monitoring, Ambulatory / Q000295:instrumentation / Q000379:methods; D015924:Blood Pressure Monitors / Q000592:standards / Q000639:trends; D018795:Device Approval; D004567:Electrodes, Implanted / Q000592:standards / Q000639:trends; D005260:Female; D006333:Heart Failure / Q000175:diagnosis* / Q000401:mortality / Q000503:physiopathology; D006801:Humans; D007902:Length of Stay / Q000706:statistics & numerical data*; D008297:Male; D010043:Outcome and Process Assessment, Health Care; D018579:Patient Selection; D011669:Pulmonary Wedge Pressure; D012107:Research Design; D014481:United States