FDA Approves First Implantable Device With Remote Monitoring to Measure PA Pressure in Heart Patients
Objective is to reduce hospitalizations for heart failure
The FDA has approved the CardioMEMS HF system (CardioMEMS, Inc.), which measures the pulmonary artery (PA) pressures and heart rates of patients with New York Heart Association (NYHA) class III heart failure who have been hospitalized for heart failure in the previous year.
The device allows health care professionals to monitor the condition of their patients remotely.
Approximately 5.8 million people in the U.S. have heart failure. With proper treatment and lifestyle changes, these individuals can live longer and more active lives. The NYHA functional classification further defines the extent of heart failure. Patients with class III heart failure experience marked limitations in physical activity, even during less-than-ordinary activity, such as walking short distances.
The CardioMEMS HF system is used by patients in the home or other remote location. It is the first permanently implantable wireless system intended to provide PA pressure measurements, including systolic, diastolic, and mean PA pressures. The PA pressure data are reviewed by physicians, who can then make decisions regarding the status of the patient and, if necessary, initiate changes in medical therapy, with the goal of reducing hospitalization due to heart failure.
The system consists of three parts: 1) a battery-free implantable sensor/monitor implanted permanently in the PA; 2) a delivery system consisting of a transvenous catheter designed to deploy the implantable sensor within the distal PA; and 3) the CardioMEMS hospital and patient electronics system, where the electronics system acquires and processes signals from the implantable sensor/monitor and transfers PA pressure measurements to a secure database.
To support the system’s approval, CardioMEMS, Inc. submitted data from its pivotal clinical study. Concerns about this study were discussed at the December 8, 2011 of the Circulatory System Devices Panel of the FDA’s Medical Devices Advisory Committee. The company provided additional follow-up data and analyses, which were discussed at the October 9, 2013 meeting of the Circulatory System Devices Panel to address these concerns.
The clinical study, in which 550 participants received the implanted device and were randomly assigned to either the control group or the investigational group, showed a clinically and statistically significant reduction in heart failure-related hospitalizations for the participants whose physicians had access to PA pressure data. Of the participants who had the device implanted (or in whom there was an attempt to implant the device), 98.6% were free from device- or system-related complications at 6 months. Of the devices implanted, all were operational at 6 months, and there were no device explants or repeat implants during this period.
The FDA believes that there is reasonable assurance that the device is safe and effective for heart failure management with the goal of reducing the rate of heart failure-related hospitalizations in certain patients. The agency is requiring a post-approval study to continue to learn about the device’s performance when used outside the context of a clinical trial.
Source: FDA; May 28, 2014.