Abbott has secured an expanded approval from the US Food and Drug Administration (FDA) for its CardioMEMS HF system to support patients with heart failure.

The expanded approval for the CardioMEMS HF system is expected to be beneficial for an additional 1.2 million patients in the US, as it provides access to an advanced monitoring with the CardioMEMS sensor.

CardioMEMS sensor is said to provide an early warning system to help doctors provide a protection against heart failure.

In 2014, the CardioMEMS HF system was first approved for use in New York Heart Association (NYHA) Class III heart failure patients with prior hospitalisation within the last year.

With the new indication, people living with Class II heart failure will be able to use the CardioMEMS sensor. It is also indicated for patients who undergo a blood test showing elevated levels of biomarkers called natriuretic peptides that indicate worsening heart failure.

CardioMEMS holds the potential to deliver actionable insights to the patients and doctors, thereby helping to manage heart failure before it advances to a later stage.

The CardioMEMS sensor is a paperclip-sized device designed to be placed in the pulmonary artery during a minimally invasive procedure to monitor pressure changes, which indicate critical heart failure.

The sensor wirelessly sends daily pressure readings to a patient’s clinical team, helping physicians to make therapy changes to reduce progression to later-stage heart failure.

Abbott heart failure business chief medical officer said: “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 expanded indication of CardioMEMS HF system was based on clinical data from the GUIDE-HF trial, which has shown enhanced outcomes with a respective 34% and 25% reduction in heart failure hospitalisations, emergency visits and death.

The trial consists of a randomised arm of 1,000 patients and a single arm of up to an additional 2,600 patients. It is currently recruiting a total of 3,600 patients across 118 centers in North America.

In January this year, Abbott secured FDA approval for its EnSite X EP System with EnSite Omnipolar Technology (OT).