FDA Expands Indication of CardioMEMS HF System for Early Stage Heart Failure

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

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

“Heart failure is a race against time where too often we are behind because patients are not receiving care early enough,” said Philip B. Adamson, MD, medical director of the heart failure business. of Abbott in a Press release. “This expanded indication means that doctors can treat more people with heart failure at an early stage, offering the possibility of preventing further suffering and possibly avoiding further progression which can have a profound impact on the quality of person’s life.”

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

It was originally approved in 2014 for use in patients with NYHA Class III heart failure who had previously been hospitalized for heat failure within the past year. Now, the new indication has allowed both people with Class II heart failure and those who have had a blood test showing elevated levels of natriuretic peptide biomarkers to use the sensor.

The GUIDE-HF included a randomized arm (n=1000) and a single arm (n=2600) for a total of 2600 patients enrolled at 118 centers in North America. In an analysis of pre-COVID-19 data, the sensor showed a significant 19% reduction in the composite endpoint of all-cause mortality and total heart failure events and a 28% reduction in hospitalizations for heart failure.

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

J. Thomas Heywood, MD, director of advanced heart failure and co-director of the Pulmonary Hypertension Program at the Scripps Clinic, noted the heart failure pandemic in the United States as the number one cause of hospitalization among 65-year-olds and more.

“Using the CardioMEMS HF System to monitor for signs of worsening heart failure has been repeatedly shown to reduce hospitalizations for patients with advanced 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 positively impact more than one million people with heart failure. .

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