The FDA has given its approval to 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. The device allows health care professionals to monitor the condition of their patients remotely. This is the first permanently implantable wireless system intended to provide PA pressure measurements, including systolic, diastolic and mean PA pressures. The results are then viewed by doctors who then use the data to determine whether changes need to be made in their treatment.
“Heart failure is one of the most common reasons for hospitalizations for people aged 65 and older,” stated Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “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.”
According to the CDC, almost 6 million people throughout the country experience heart failure (a condition in which the heart cannot pump an adequate supply of blood through the body). However, patients with heart failure can live “longer and more active lives with proper care and lifestyle changes.”
For more information readers can contact the FDA at 888-Info-FDA.