FDA Expands Eligibility for CardioMEMS Heart Failure System

Megan Brooks

February 23, 2022

The US Food and Drug Administration (FDA) has expanded the indication for Abbott's CardioMEMS heart failure (HF) system, making an additional 1.2 million patients in the United States eligible for the implantable HF sensor, according to the company.

The CardioMEMS HF system remotely monitors changes in pulmonary artery pressure, providing early warning of worsening HF.

The FDA first approved the system in 2014 for use in patients with New York Heart Association (NYHA) class III HF and a HF hospitalization in the previous year.

The new indication permits the use of the CardioMEMS sensor in patients with NYHA class II HF and in those with worsening HF determined by elevated natriuretic peptides.

"Heart failure is a race against time where too often we're behind because patients are not getting care early enough," Philip B. Adamson, MD, chief medical officer of Abbott's heart failure business, said in a company news 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," Adamson says.

Results of the GUIDE-HF trial supported the expanded indication, Abbott said.

After adjustment for the impact of COVID-19, compared with conventional HF management, both class II HF patients and patients with elevated natriuretic peptides, using the CardioMEMS HF monitoring system, had a respective 34% and 25% reduction in HF hospitalizations, emergency visits, and death, the company reports.

The results of GUIDE-HF were presented in August 2021 at the European Society of Cardiology (ESC) Congress, simultaneously published in the Lancet, and reported by theheart.org | Medscape Cardiology at that time.   

"As the number one cause for hospitalizations in people age 65 and over, heart failure is its own pandemic in the United States," J. Thomas Heywood, MD, director of Advanced Heart Failure and codirector of the pulmonary hypertension program at Scripps Clinic in La Jolla, California, says in the news release. 

"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 says.

"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," he adds.

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