Thirty years ago, heart failure was a death sentence.
Today, it's not.
Helping drive this transition has been CardioMEMS HF System, Abbott’s leading remote monitoring technology that tracks blood pressures in the lung circulation (pulmonary artery) and wirelessly transmits from virtually anywhere, to the patient's clinical team. Data from this paperclip-sized device allow doctors to intervene, if necessary, before heart failure worsens.
And now, the U.S. Food and Drug Administration (FDA) has approved expanding the indication for CardioMEMS beyond people with more advanced (Class III) heart failure to those in earlier stages of the condition (Class II), and for patients who undergo a blood test showing elevated levels of certain biomarkers that indicate worsening heart failure.
Here's What This Means
Significantly more Americans are now eligible to receive the remote heart-failure sensor, enabling broader access to the life-changing technology.
How many more?
With the approval, an additional 1.2 million people in the U.S.1 are now eligible for this technology.
The expanded indication was supported by data from the large GUIDE-HF trial, which found that people with earlier-stage heart failure (Class II) have better outcomes with fewer hospitalizations when their therapy is guided by remote pulmonary pressure monitoring.
"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 approval 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."
FOLLOW ABBOTT