The approval of the expanded indication, announced yesterday, means that an additional 1.2 million people in the U.S. with heart failure could take advantage of the Abbott system. The CardioMEMS HF system remotely monitors pulmonary artery (PA) pressure changes, providing early warning of worsening heart failure.
FDA initially approved the system in 2014 for use in Class III heart failure patients previously hospitalized for their condition over the past year. It’s now also approved for Class II patients and people with blood test results showing worsening heart failure as a result of elevated natriuretic peptides.
“Heart failure is a race against time where too often we’re behind because patients are not getting care early enough,” said Dr. Philip B. Adamson, 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.”
GUIDE-HF trial results supported the expanded indication, according to Abbott. Based on data adjusted for the impact of COVID-19, both Class II heart failure patients and patients with elevated natriuretic peptides saw a respective 34% and 25% reduction in heart failure hospitalizations, emergency visits and death with CardioMEMS HF monitoring.