Abbott’s CardioMEMS HF system receives FDA approval for use in earlier-stage heart failure


Abbott has announced that the US Food and Drug Administration (FDA) has approved an expanded indication for the company’s CardioMEMS HF system to support the care of more people living with heart failure.

With the expanded indication, an additional 1.2 million US patients are now eligible to benefit from advanced monitoring with the CardioMEMS sensor, which marks a significant increase over the current addressable population, Abbott said in a press release. The CardioMEMS sensor provides an early warning system enabling doctors to protect against worsening heart failure.

The CardioMEMS sensor is a paperclip-sized device that, once placed in the pulmonary artery during a minimally invasive procedure, monitors for pressure changes that indicate worsening heart failure. The sensor wirelessly transmits daily pressure readings to a patient’s clinical team—allowing physicians to make therapy changes to combat progression to later-stage heart failure while empowering the patient to manage their condition from virtually anywhere.

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 hospitalisation 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 are behind because patients are not getting care early enough,” said 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.”

The CardioMEMS HF System’s expanded indication was supported by clinical data from the GUIDE-HF trial. Based on study data adjusted for the impact of COVID-19, both Class II heart failure patients and patients with elevated natriuretic peptides were suggested to have better outcomes when their therapy was guided by pulmonary pressure monitoring, with a respective 34% and 25% reduction in heart failure hospitalisations, emergency visits and death, Abbott’s press release adds.

“As the number one cause for hospitalisations in people age 65 and over, heart failure is its own pandemic in the USA,” said J Thomas Heywood, director of Advanced Heart Failure and co-director of the Pulmonary Hypertension Program at Scripps Clinic, La Jolla, USA. “Utilising the CardioMEMS HF system to monitor for signs of worsening heart failure has been shown repeatedly to reduce hospitalisations for patients with later-stage heart disease. The new data provided by the GUIDE-HF study means we can extend these benefits to less sick patients. In the USA alone, this could have a positive impact for more than a million people suffering from heart failure.”


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