Patients living with chronic heart failure, and their doctors, are looking for ways to reduce hospitalizations and help manage heart failure before it advances to a later stage. Patients need to get care early enough to prevent further suffering and to avoid later-stage heart failure.
Supported by data from the GUIDE-HF trial, the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Abbott’s CardioMEMS™ HF System to treat people with earlier-stage heart failure.
This significantly increases the current addressable population by making an additional 1.2 million United States patients eligible to access increased monitoring with the CardioMEMS sensor.
According to Abbott, 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.
This sensor is a small implantable device, about the size of a paperclip, that provides an early alert to signs of worsening heart failure. The patient undergoes a minimally invasive procedure as the device is placed in the pulmonary artery, allowing it to detect changes in blood pressure. The sensor can then wirelessly transmit daily pressure readings to the patient’s doctor, while empowering the patient to manage their condition remotely from anywhere.
Abbott’s press release said that more than 6.2 million Americans have heart failure, with diagnoses projected to double by 2030.
This expanded indication means more patients with earlier-stage heart failure can be treated by their physician, providing the opportunity to avoid later-stage progression and profoundly improve a person’s quality of life.