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Abbott’s CardioMEMS™ HF System Receives FDA Approval to Support Patients Battling Earlier-stage Heart Failure

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Abbott's CardioMEMS™ HF System Receives FDA Approval to Support Patients Battling Earlier-stage Heart Failure | Pharmtech Focus

Abbott today announced that the U.S. 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 U.S. patients are now eligible to benefit from advanced monitoring with the CardioMEMS sensor, which marks a significant increase over the current addressable population. The sensor provides an early warning system enabling doctors to protect against worsening heart failure.

More than 6.2 million Americans have heart failure, with diagnoses projected to double by 2030. While heart failure is a chronic disease, medical options like CardioMEMS can provide patients and their doctors with actionable insights to help manage heart failure before it progresses to a later stage. 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 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.”

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