FDA Approves Implantable Device, CardioMEMS HF System, For Heart Failure Patients

cardiomems
The FDA recent approval of a heart failure monitoring device will allow physicians to check up on patients' health remotely. Intel Free Press, CC BY-SA 2.0

The Food and Drug Administration (FDA) announced Thursday its approval for the first wireless implantable device, known as CardioMEMS HF System, designed to monitor the health of heart failure patients remotely.

Manufactured by CardioMEMS Inc., located in Atlanta, Ga., the device is meant to give health care professionals an early look at pulmonary artery (PA) pressure data, which they can use to change medication dosage or treatment method before the need for hospitalization. In the clinical study leading up to the FDA’s approval, 98.6 percent of subjects using the device saw no device-related complications within six months, and, of the devices implanted, 100 percent were operational within the same timeframe.

“Heart failure is one of the most common reasons for hospitalizations for people aged 65 and older,” said Christy Foreman, director in the FDA’s Center for Devices and Radiological Health, in the news release. According to the Centers for Disease Control and Prevention, roughly half of all people who develop heart failure die within five years of diagnosis, straining the national economy to the tune of $32 billion annually.

Heart failure occurs when the heart is no longer able to pump enough blood and oxygen to the surrounding parts of the body. While this doesn’t mean the heart necessarily stops beating altogether, the pulse it sends is too weak to replenish major organs. In typical cases, the blood that would normally leave the heart through the aorta never exits the muscle, recycling back into the heart and pooling in the surrounding valves. In congestive heart failure cases, blood may pool in other major organs as well.

The new device is intended to monitor the pressure of this outgoing blood. If the data shows the pressure is too low, physicians located remotely can check up on patients to gauge their health. Not all heart failure patients qualify for the device, the FDA explains. Only people with New York Heart Association (NYHA) Class III heart failure, who have been hospitalized for heart failure in the previous year, are eligible.

The device comes in three parts: a battery-free Implantable Sensor/Monitor implanted permanently in the pulmonary artery, a transvenous catheter designed to deploy the Implantable Sensor, within the distal PA, and the remote sensor that tracks patient data that gets delivered to the monitoring physician.

“The goal of this first-of-its-kind implantable wireless device with remote monitoring of pulmonary artery pressure is to reduce heart failure-related hospitalizations,” Foreman said. The agency expressed its belief that the CardioMEMS HF System was safe and effective for heart failure management. It is also requiring a thorough Post-Approval Study to gain even more information about the device’s success, given its move from clinical to personal use.

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