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Recent Device Approvals: CardioMEMS HF System

The U.S. Food and Drug Administration has recently approved the CardioMEMS HF System to be marketed.  The CardioMEMS HF System measures and monitors the pulmonary artery (PA) pressure and heart rate in certain heart failure patients. The System consists of an implantable PA sensor, delivery system, and Patient Electronics System. The implantable sensor is permanently placed in the pulmonary artery, the blood vessel that moves blood from the heart to the lungs. The sensor is implanted during a right heart catheterization procedure. The PA sensor is about the size of small paper clip and has a thin, curved wire at each end. This sensor does not require any batteries or wires.  The delivery system is a long, thin, flexible tube (catheter) that moves through the blood vessels and is designed to release the implantable sensor in the far end of the pulmonary artery.  The Patient Electronics System includes the electronics unit, antenna and pillow. Together, the components of the Patient Electronics System read the PA pressure measurements from the sensor wirelessly and then transmit the information to the doctor. The antenna is paddle-shaped and is pre-assembled inside a pillow to make it easier and more comfortable for the patient to take readings.  For more information, please see http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm400550.htm


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