FDA Expands CardioMEMS HF System Indication For Earlier-Stage Heart Failure

US Food and Drug Administration

The US Food and Drug Administration has approved an expanded indication for Abbott’s CardioMEMS HF System to include patients with New York Heart Association (NYHA) Class II heart failure, based on data from the GUIDE-HF trial.

Announced today, the expanded indication made an additional 1.2 million patients in the United States eligible for the advanced monitoring, a significant increase over the current addressable population. The sensor aims to provide an early warning system for clinicians to protect against worsening heart failure.

“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 in a press release. "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."

The sensor is a paperclip-sized device placed in the pulmonary artery during a minimally invasive procedure and then monitors for pressure changes that indicate worsening heart failure, transmitting daily pressure readings to a clinical team.

It was initially approved in 2014 for use in NYHA Class III heart failure patients with a prior heat failure hospitalization within the last year. Now, the new indication has allowed both those with Class II heart failure and those who underwent a blood test showing elevated biomarker levels of natriuretic peptide to use the sensor.

The GUIDE-HF included a randomized arm (n = 1,000) and a single arm (n = 2,600) for a total of 2,600 patients enrolled across 118 centers in North America. In an analysis of data prior to COVID-19, the sensor showed a significant 19% reduction in the composite endpoint of all-cause mortality and total heart failure events and 28% reduction in heart failure hospitalizations.

After adjustment for the impact of COVID-19, data from the analyses suggested both NYHA Class II patients and patients with elevated natriuretic peptides saw better outcomes when guided by the CardioMEMS HF System. A 34% and 25% reduction in the primary composite endpoint was observed, respectively.

J. Thomas Heywood, M.D., director of Advanced Heart Failure and co-director of the Pulmonary Hypertension Program at Scripps Clinic noted the pandemic of heart failure in the United States as the number one cause for hospitalizations in those 65 years and older.

"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,” Heywood said. “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."