CardioMEMS Champion Heart Failure Monitoring System
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. (J Am Coll Cardiol 2013;61:1571–6) © 2013 by the American College of Cardiology Foundation
The CardioMEMS Champion Heart Failure Monitoring System (CardioMEMS, Atlanta, Georgia) is a permanently implantable pressure measurement system designed to provide daily pulmonary artery (PA) pressure measurements in an ambulatory setting and thus help guide heart failure (HF) management in an outpatient setting to reduce HF hospital stays. The system consists of an implantable sensor/monitor, which is a battery-free capacitive pressure sensor permanently implanted in the PA; a transvenous delivery system designed to deploy the implantable sensor in the distal PA; and the Champion Electronics System (CardioMEMS), which acquires and processes signals from the implantable sensor/monitor and transfers PA pressure measurements to a secure database accessible by the treating physician.
On December 8, 2011, the Food and Drug Administration (FDA) Circulatory System Devices Panel reviewed the CardioMEMS Champion HF Monitoring System premarket approval (PMA) application. Meeting materials can be accessed at the FDA website.
The PMA application was primarily based on data from the pivotal, prospective, multi-centered, randomized, single-blinded CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) trial, which was published in the Lancet earlier this year, which consisted of patients in New York Heart Association (NYHA) functional class III HF with a previous hospital stay within the last year; 270 patients were randomized to PA pressureguided treatment of HF compared with 280 in the control arm. Of note, all patients underwent implantation of the device, but no PA pressure measurements were performed in the control group.
The following is a summary of the discussions and recommendations made during the Circulatory System Devices Advisory Panel meeting.
Abstract and Introduction
Abstract
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. (J Am Coll Cardiol 2013;61:1571–6) © 2013 by the American College of Cardiology Foundation
Introduction
The CardioMEMS Champion Heart Failure Monitoring System (CardioMEMS, Atlanta, Georgia) is a permanently implantable pressure measurement system designed to provide daily pulmonary artery (PA) pressure measurements in an ambulatory setting and thus help guide heart failure (HF) management in an outpatient setting to reduce HF hospital stays. The system consists of an implantable sensor/monitor, which is a battery-free capacitive pressure sensor permanently implanted in the PA; a transvenous delivery system designed to deploy the implantable sensor in the distal PA; and the Champion Electronics System (CardioMEMS), which acquires and processes signals from the implantable sensor/monitor and transfers PA pressure measurements to a secure database accessible by the treating physician.
On December 8, 2011, the Food and Drug Administration (FDA) Circulatory System Devices Panel reviewed the CardioMEMS Champion HF Monitoring System premarket approval (PMA) application. Meeting materials can be accessed at the FDA website.
The PMA application was primarily based on data from the pivotal, prospective, multi-centered, randomized, single-blinded CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) trial, which was published in the Lancet earlier this year, which consisted of patients in New York Heart Association (NYHA) functional class III HF with a previous hospital stay within the last year; 270 patients were randomized to PA pressureguided treatment of HF compared with 280 in the control arm. Of note, all patients underwent implantation of the device, but no PA pressure measurements were performed in the control group.
The following is a summary of the discussions and recommendations made during the Circulatory System Devices Advisory Panel meeting.
