Abbott gets USFDA nod for expanded indication of CardioMEMS HF System

The CardioMEMS HF System was initially approved in 2014 for use in New York Heart Association (NYHA) Class III heart failure patients with a prior heart failure hospitalization within the last year. The new indication allows the CardioMEMS sensor to be used by people living with Class II heart failure and for patients who undergo a blood test showing elevated levels of biomarkers known as natriuretic peptides, which indicate 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, M.D., 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."