First Wireless Implant to Measure PA Pressure

The FDA has approved the CardioMEMS HF System that 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. This marks the first permanently implantable wireless system that provides PA pressure measurements, including systolic, diastolic and mean PA pressures.

Patients use the CardioMEMS HF System in their homes or other remote locations. Healthcare professionals are able to monitor their patients’ PA conditions remotely through this wireless device and make changes in medical therapy if clinically necessary.

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The CardioMEMS HF System consists of a battery-free implantable sensor/monitor implanted in the PA, a delivery system that deploys the implantable senor within the distal PA, and a CardioMEMS Hospital and Patient Electronics System where signals from the implantable sensor/monitor and PA pressure measurements are transferred to a secure database.

A clinical study that supported its approval enrolled 550 participants that had the device implanted. Data showed a clinically and statistically significant reduction in heart-failure related hospitalizations for the participants whose doctors had access to PA pressure data. Of those who had the device implanted, 98.6% were free of device/system-related complications at 6 months, and 100% were operational at 6 months.

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