The U.S. Food and Drug Administration has approved the first permanently implantable wireless device with remote monitoring to measure pulmonary artery pressure in certain heart failure patients.
The device, manufactured by CardioMEMS Inc. in Atlanta, Ga., remotely measures the pulmonary artery pressures and heart rates of patients with New York Heart Association Class III heart failure who have been hospitalized for heart failure in the previous year. The device can be used at home or other remote locations. Patients with Class III heart failure experience marked limitation in physical activity, even during less-than-ordinary activity such as walking short distances.
The CardioMEMS HF System provides pulmonary artery pressure measurements, including systolic, diastolic and mean PA pressures. At a hospital, the system acquires and processes signals from a patient's implantable sensor/monitor and transfers PA pressure measurements to a secure database. The PA pressure data are then reviewed by physicians who can make decisions regarding the status of the patient and, if necessary, initiate changes in medical therapy, with the goal of reducing hospitalization due to heart failure.
"The FDA believes that 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," according to a statement by the regulatory agency.
In a recent clinical study, 550 participants with the device implanted were randomized into either a control group or investigational group. Patients whose doctors had access to pulmonary artery pressure data had a clinically and statistically significant reduction in heart failure-related hospitalizations. The FDA is requiring a thorough post-approval study to continue to learn about the devices performance when used outside the context of a clinical study.
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