FDA Approves New Wireless Device for Heart Failure Patients
The agency has approved the first-ever implantable wireless device with remote monitoring to measure pulmonary artery pressure and heart rate in patients with heart failure.
The FDA announced it has approved the CardioMEMSHF System, the first implantable, wireless device with remote monitoring to measure pulmonary artery pressure and heart rate in certain patients with heart failure. The device is approved to be used in patients with New York Heart Association (NYHA) Class III heart failure who have "been hospitalized for heart failure in the previous year," according to the FDA.
The device allows health care professionals to monitor the condition of their heart patients remotely, as the device is used by patients in their homes or other remote locations. The device—which provides information on systolic, diastolic, and mean PA pressures—sends data to physicians who can then make decisions for the patient and, if necessary, make changes in medical therapy.
According to the FDA, the device consists of three parts:
- A battery-free Implantable Sensor/Monitor implanted permanently in the PA;
- Delivery System, a transvenous catheter designed to deploy the Implantable Sensor, within the distal PA; and
- CardioMEMS Hospital and Patient Electronics Systems where the Electronics System acquires and processes signals from the Implantable Sensor/Monitor and transfers PA pressure measurements to a secure database.
Currently, 5.8 million people in the United States have heart failure. "Heart failure is one of the most common reasons for hospitalizations for people aged 65 and older," said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. "The goal of this first-of-its-kind implantable wireless device with remote monitoring of pulmonary artery pressure is to reduce heart failure-related hospitalizations."