CardioMEMS Hospital Electronics System CM3000 - Active-implantable-device communicator

Intended purpose

The CardioMEMS HF System is indicated for wirelessly measuring and monitoring pulmonary artery pressure in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year. The haemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations. The CardioMEMS HF System is used by the physician in the hospital or office setting to obtain and review PA pressure measurements. The CardioMEMS HF System is used by the patient in the home to wirelessly obtain and send hemodynamic and PA pressure measurements to a secure database for review and evaluation by the patient’s physician.

Functional description

The Hospital Electronics System contains an electronics unit and an antenna. It is designed to obtain information from the implanted pulmonary artery (PA) sensor. It is used during the implant procedure and when measurements are taken in a clinical setting. The antenna sends a RF signal to energise the sensor and receives the RF signal from the PA sensor, for processing by the electronics unit.