February 25, 2022 – Abbott has 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. patients1 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 failure2, with diagnoses projected to double3 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.