February 21, 2022 – Abbott 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’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 hospitalizations, emergency visits and death.