FDA Approves First Remote Monitoring Device For Heart Failure Patients
The U.S. Food and Drug Administration (FDA) announced its approval of the CardioMEMS HF System, the first implantable wireless device equipped with remote monitoring to assess pulmonary artery (PA) pressure in specific heart failure patients.
The device is manufactured by CardioMEMS, Inc. for remote monitoring of patients with New York Heart Association (NYHA) Class III heart failure who have undergone prior hospitalized for heart failure. The system provides PA pressure measurements including systolic, diastolic, and mean PA pressures. These data help physicians make decisions or changes in therapy based on the patient’s status.
An estimated 5.8 million people in the U.S. suffer from heart failure. According to the NYHA Functional Classification, patients with Class III heart failure experience physical limitations, finding it difficult to carry out simple physical tasks, such as a simple walk across short distances.
“Heart failure is one of the most common reasons for hospitalizations for people aged 65 and older. 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,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.
The approval was based on data from the company’s pivotal clinical study, which showed clinically and statistically meaningful reduction in heart failure-related hospitalizations in participants whose physicians had access to PA pressure data provided by the device. Of patients who had the device implanted or tried to get the device implanted, 98.6 percent were reported to be free from device-associated complications. Of those who had the device successfully implanted, 100 percent were operational at 6 months. No devices had to be removed or implanted again during the period. The trial involved 550 participants with heart failure.
The FDA is currently awaiting results from a requested thorough Post-Approval Study from the company to ascertain the device’s performance outside a clinical study.