FDA approves next-generation CardioMEMS reader for heart failure monitoring
Abbott has secured U.S. Food and Drug Administration (FDA) approval for its CardioMEMS HERO device, a next-generation pulmonary artery (PA) pressure reader for heart failure patients.
The company’s CardioMEMS platform has been used for years to provide wireless, battery-free PA monitoring in patients with significant heart failure symptoms. A tiny sensor is implanted near the heart, and then the reader can be used to capture readings in under a minute. The CardioMEMS Hero is 60% lighter than the previous PA readers used with this technology, giving patients a more compact treatment option.
Another key update with CardioMEMS Hero is the fact that it has Wi-Fi and cellular connectivity built into the device. This allows patients to take readings in a wider variety of locations.
“Hero is likely to significantly enhance data acquisition and patient interactions with this life-changing technology,” JoAnn Lindenfeld, MD, director of advanced heart failure at Vanderbilt University Medical Center, said in a statement. “HERO is lighter, more comfortable, and easier to transport and use which improves patient experience.”
“Abbott’s CardioMEMS Hero reader is modernizing a proven and effective remote patient management system, making it even more convenient for patients to use a device that has shown a 57% reduction in heart failure hospitalizations,” added Finn Gustafsson, MD, PhD, chief medical officer and divisional vice president of Abbott’s heart failure business. “With this new reader, people can work with their doctors to proactively manage their condition outside of the doctor’s office even more efficiently – increasing convenience and the patient experience.”
One critical study on the CardioMEMS technology was published in Circulation: Heart Failure in 2020.[1] The device was linked to lower PA pressures, lower rates of heart failure hospitalization and all-cause hospitalization and a reduced risk of adverse events. Click here to read the full analysis.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.