The first wireless implantable hemodynamic monitoring system for patients with heart failure has been approved by the FDA.
First Implantable Device to Remotely Monitor Heart Failure Patients
The first wireless implantable hemodynamic monitoring system for patients with heart failure has been approved by the FDA. The Champion HF Monitoring System, a product of CardioMEMS, measures mean pulmonary artery pressures and heart rate, and is approved for NYHA class 3 patients with a history of hospitalizations within the past year. It is used in either the hospital or office setting.
The FDA stated that there was a 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 device consists of a sensor/monitor implanted permanently in the pulmonary artery, a transvenous catheter to deliver and deploy the sensor, and an electronics system that acquires and processes the signal from the sensor and transfers the pulmonary artery pressure measurements to a secure database.
The approval of the device was based largely on data from the CHAMPION trial, which showed that the Champion HF Monitoring System reduced hospitalizations 30% compared with standard care.