Abbott’s CardioMEMS HF System Approved for Expanded Indication to Treat Earlier-Stage Heart Failure

February 21, 2022—Abbott announced that the FDA has approved an expanded indication for the company’s CardioMEMS HF system to support the treatment of patients with heart failure (HF).

According to Abbott, the CardioMEMS sensor provides an early warning system enabling doctors to protect against worsening HF. The device was initially approved in 2014 for use in New York Heart Association Class III HF patients with a HF hospitalization within the previous year.

The new indication allows the CardioMEMS sensor to be used by people living with Class II HF and for patients who undergo a blood test showing elevated levels of natriuretic peptides, which indicate worsening HF.

The company stated that the expanded indication allows an additional 1.2 million patients in the United States to be eligible to receive monitoring with the CardioMEMS sensor.

The CardioMEMS sensor is placed in the pulmonary artery to monitor pressure changes that indicate worsening HF. The sensor wirelessly transmits daily pressure readings to a patient’s clinical team, thereby allowing physicians to make therapy changes to combat progression to later-stage HF patients can manage their condition from virtually anywhere.


Abbott advised that the CardioMEMS HF system’s expanded indication was supported by clinical data from the GUIDE-HF trial. Based on study data adjusted for the impact of COVID-19, both Class II HF patients and patients with elevated natriuretic peptides were suggested to have better outcomes when their therapy was guided by pulmonary pressure monitoring, with a respective 34% and 25% reduction in HF hospitalizations, emergency visits, and death.

The GUIDE-HF trial study included a randomized arm of 1,000 patients and a single arm of up to an additional 2,600 patients that is currently enrolling for a total of 3,600 patients across 118 centers in North America. All patients were implanted with a CardioMEMS sensor, but therapy for patients in the control arm was not guided by the device. In an analysis of data adjusted for the impact of COVID-19 (captured before March 13, 2020—the date the United States national emergency was declared), CardioMEMS demonstrated a significant 19% reduction in the study’s composite endpoint and a 28% reduction in HF hospitalizations, noted the company.

The results of GUIDE-HF were presented at the European Society of Cardiology’s ESC Congress 2021 held virtually August 27-30, and simultaneously published by Professor JoAnn Lindenfeld, MD, et al in The Lancet (2022;98:991-1001).

“As the number one cause for hospitalizations in people age 65 and over, HF is its own pandemic in the United States,” commented J. Thomas Heywood, MD, in Abbott’s press release. Dr. Heywood, who is director of Advanced Heart Failure and co-director of the Pulmonary Hypertension Program at Scripps Clinic in La Jolla, California, continued, “Utilizing the CardioMEMS HF system to monitor for signs of worsening HF has been shown repeatedly to reduce hospitalizations for patients with later-stage heart disease. The new data provided by the GUIDE-HF study means we can extend these benefits to less sick patients. In the United States alone, this could have a positive impact for more than a million people suffering from HF.”