Abbott’s Next-Generation CardioMEMS™ HERO Reader Receives FDA Approval

Abbott has announced that the U.S. Food and Drug Administration (FDA) has approved its CardioMEMS™ HERO device, a next-generation pulmonary artery (PA) pressure reader designed to support people living with heart failure. The new reader is an advanced component of the CardioMEMS™ HF System and aims to enhance patient experience while enabling earlier detection of disease progression.

Heart failure is a chronic and progressive condition in which the heart cannot pump blood efficiently. If untreated, it can lead to fluid accumulation, breathing difficulties, organ damage, irregular heart rhythms, and death. Nearly 6.7 million people in the United States currently live with heart failure, with projections estimating the number could rise to 8.5 million by 2030.

The CardioMEMS HERO reader is smaller, sleeker, and 60% lighter than the previous model. Roughly the size of a laptop case, it is designed for convenient daily use and easier portability, including during travel. The device works alongside the CardioMEMS PA Sensor — a small implant placed near the heart that monitors rising pulmonary artery pressures, an early indicator of worsening heart failure.

Patients simply lie on the reader for less than 60 seconds on average to capture a remote PA pressure reading, which is securely transmitted to their healthcare team. Clinicians can review daily data trends and adjust medications or recommend lifestyle changes if pressures rise — often before symptoms appear — helping reduce hospitalizations.

Key features of the HERO reader include:
Greater Convenience: 
60% lighter and travel-friendly design.
Accurate Results: 
Improved positioning for consistent daily readings.
Enhanced Connectivity: 
Integrated Wi-Fi and cellular connectivity for easier setup and data transmission.

"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."

Abbott states that the CardioMEMS HF System has been clinically proven to reduce hospital readmissions, improve quality of life, and support survival by serving as an early warning system. The HERO reader is compatible with the currently available 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."

Abbott plans to begin commercial release of the CardioMEMS HERO reader in the United States soon.