Abbott today announced the U.S. Food and Drug Administration (FDA) has approved the company’s CardioMEMS™ HERO device supporting patients with heart failure. According to the company press release, the reader contains new design features to help empower heart failure patients and their clinicians with the daily insights they need to detect and combat heart failure progression. Abbott says it will soon begin commercial release of the CardioMEMS HERO reader in the United States.
The CardioMEMS HERO reader is a new component of the CardioMEMS™ HF System. The HERO reader is similar in size to a laptop case and is sleeker and smaller than the system’s previous model. It is designed to work with the CardioMEMS PA Sensor – a paperclip-sized device implanted near the heart where rising PA pressures signal worsening heart failure.
Patients lay with their back centered on the HERO reader for less than 60 seconds on averageii to take a remote PA pressure reading and securely send the data to their care team. Clinicians will receive the daily data readings and if they see changes in PA pressures, they will communicate to the patient any medication or lifestyle changes needed to help slow heart failure progression – often before a patient even feels symptoms – to keep them out of the hospital.
“Data from CardioMEMS HF System clinical trials show the positive impact the device has on reducing the risk of heart failure hospitalizations and cardiovascular death. HERO is likely to significantly enhance data acquisition and patient interactions with this life-changing technology,” said JoAnn Lindenfeld, M.D., director of advanced heart failure at Vanderbilt University Medical Center in Nashville, Tenn, who served as primary investigator for the GUIDE-HF study – the largest randomized clinical trial conducted on pulmonary artery pressure monitoring. “HERO is lighter, more comfortable, and easier to transport and use which improves patient experience.”
According to the comany, the Abbott CardioMEMS™ HF System is clinically proven to reduce hospital readmissionsiv, and improve quality of life and survivalv, by serving as an early warning tool. The CardioMEMS PA Sensor is implanted during a minimally invasive outpatient procedure. The HERO reader is compatible with the current commercially available version of the CardioMEMS PA Sensor.
“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 hospitalizationsvi,” said Finn Gustafsson, M.D., Ph.D., 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.”
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