FDA Approves First Implantable Device for Remotely Monitoring HF Patients

BETHESDA, MD – The US Food and Drug Administration (FDA) has approved the first wireless implantable hemodynamic monitoring system for patients with heart failure (HF)[1], stating 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 Champion HF Monitoring System (CardioMEMS, Atlanta, GA), which measures mean pulmonary-artery (PA) pressures and heart rate, is approved for NYHA class 3 patients with a history of hospitalizations within the past year.

The approval was based largely on an open-label study conducted with patients enrolled in the CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients (CHAMPION) trial. In the CHAMPION study, previously reported by heartwire , the PA-pressure sensor implanted in NYHA class 3 heart-failure patients with a history of decompensation reduced hospitalizations 30% compared with standard care.

In 2013, an FDA advisory panel narrowly voted in favor of approving the permanent diagnostic implant, with a 6–4 favorable vote on the question of risk vs benefit. The pass before the advisory committee, however, was the second go-round for the CardioMEMS device. In 2011, an advisory panel voted 6–4 against approving, stating the sponsor and clinical investigators hadn't shown the benefits outweighed the risks.

In the 2013 advisory panel, the company provided additional follow-up on the 550 patients who had the device implanted.

The device consists of a sensor/monitor implanted permanently in the PA, 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 PA-pressure measurements to a secure database. It can be used in the hospital or office setting.

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