News | FDA | February 27, 2026

FDA Grants Approval for Abbott's CardioMEMS Hero Device

Abbott's latest generation of remote heart failure monitoring technology is designed to improve how patients take and send daily pulmonary artery pressure readings to their clinicians to monitor for signs of worsening heart failure.

remote heart monitor, heart failure, pulmonary artery

Feb. 27, 2026 — The U.S. Food and Drug Administration (FDA) has approved Abbott’s CardioMEMS Hero device — a pulmonary artery (PA) pressure reader — to support the care of people living with heart failure. 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 will soon begin commercial release of the CardioMEMS Hero reader in the United States.

Heart failure is a progressive condition that occurs when the heart can't circulate blood efficiently. If left untreated, symptoms can rapidly progress, leading to breathing difficulties, fluid build-up in the lungs, organ damage, irregular heart rhythms and death. Approximately 6.7 million people in the United States have heart failure, and that number is expected to grow to 8.5 million by 2030.1

CardioMEMS HERO improves patient experience

Abbott’s 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 average2  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.

Hero’s features include:

  • Greater Convenience: The Hero reader is 60% lighter than the previous model, so its smaller size makes it easy for patients to use every day. It’s also designed to fit in a carry-on suitcase, making travel more convenient.
  • Accurate Results: The improved Hero design enables a consistent reading position for the patient that provides reliable daily PA pressure trends to the care team.
  • Enhanced Connectivity: Hero is the only patient reader with integrated Wi-Fi and cellular connectivity that makes setup easy, allowing patients to take a reading virtually anywhere they have a signal.3

"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."

CardioMEMS HF System Helps Reduce Hospitalizations

Abbott’s CardioMEMS HF System is clinically proven to reduce hospital readmissions4, and improve quality of life and survival5 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 hospitalizations6," 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."

 

  1. Bozkurt, et. al. Heart Failure Epidemiology and Outcomes Statistics: A Report of the Heart Failure Society of  America. J Card Fail. 2023; 29(10): 1412–1451.
  2. Abbott data on file, based on internal validation studies with representative users. Results may vary.
  3. Abbott data on file.
  4. Abraham J, et al. JAMA Cardiology. 2019 (30% at 12 months vs CMS database matched controls
    Givertz et al. J Am Coll Cardiology 2017. (32% in CHAMPION Tx vs Control)
    Lindenfeld et al. (2024) 136 Meta-Analysis w/LAPTOP (25% mortality reduction overall at 2 years)
    Zile et al. (2025) Meta Analysis (CHAMPION, GUIDE, USPAS) 
  5. Brugts et al. (2023) 121 MONITOR-HF
  6. Shavelle D, Desai A, Abraham W, et al. Lower rates of heart failure and all-cause hospitalizations during pulmonary artery pressure-guided therapy for ambulatory heart failure. Circulation: Heart Failure. 2020;13(8):229-238.

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