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FDA Expands Indication for CardioMEMS HF System, Includes NYHA Class II, Worsening HF Patients

Announced by Abbott on Feb. 21, the expanded indication for the CardioMEMS HF System now includes patients with NYHA Class II heart failure and those with worsening heart failure, which expands the potential patient population by 1.2 million additional patients.

The US Food and Drug Administration has approved an expanded indication for CardioMEMS HF System to include patients with NYHA Class II heart failure and those with worsening heart failure, according to a press release from Abbott.

Announced on February 21, the expanded indication is based on results of the GUIDE-HF trial and expands the potential patient population for advanced monitoring with the CardioMEMS HF System by 1.2 million additional US patients.

"As the number one cause for hospitalizations in people age 65 and over, heart failure is its own pandemic in the United States," said J. Thomas Heywood, MD, director of Advanced Heart Failure and co-director of the Pulmonary Hypertension Program at Scripps Clinic in La Jolla, Calif. "Utilizing the CardioMEMS HF System to monitor for signs of worsening heart failure 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 heart failure."

When the initial approval for the CardioMEMS HF System was awarded in 2014, it was for the use in patients with NYHA Class III heart failure with prior heart failure hospitalization within the past year. The most recent approval, which was supported by results of GUIDE-HF, indicates the system for use in patients with NYHA Class II heart failure and for patients who undergo a blood test showing elevated levels of biomarkers known as natriuretic peptides.

All patients included in the GUIDE-HF trial were implanted with a CardioMEMS sensor and underwent randomization in a 1:1 ratio to management with hemodynamic monitoring and titration based on pulmonary artery pressures. An analysis adjusted for the impact of COVID-19 provided evidence that suggested use of the CardioMEMS HF System was associated with a significant 19% reduction in the study's composite endpoint of all-cause mortality, heart failure hospitalizations, or urgent heart failure visits and a 28% reduction in heart failure hospitalizations.

The release from Abbott noted results of the same analysis suggested both NYHA Class II heart failure patients and patients with elevated natriuretic peptides experienced better outcomes when their therapy was guided by the CardioMEMS HF System, with 34% and 25% reductions in the primary composite endpoint, respectively.

"Heart failure is a race against time where too often we’re behind because patients are not getting care early enough," said Philip B. Adamson, MD, chief medical officer of Abbott's heart failure business. "This expanded indication means physicians can treat more people with earlier-stage heart failure, providing the opportunity to prevent further suffering and possibly avoid later-stage progression that can have a profound impact on a person’s quality of life."