Sam Brusco, Associate Editor02.22.22
Abbott Labs has earned U.S. Food and Drug Administration (FDA) approval to expand its CardioMEMS HF system to patients suffering from earlier-stage heart failure. According to Abbott Heart Failure Navigant Data, this label expansion will make 1.2 million more patients eligible to use CardioMEMS sensor monitoring.
The paperclip-sized CardioMEMS, placed in the pulmonary artery via a minimally invasive procedure, monitors pressure changes that indicate worsening heart failure. The sensor transits daily pressure readings to the clinical team so therapy changes can be made to prevent progression to later-stage heart failure.
It was specifically approved for Class II heart failure patients and those whose blood test results show elevated natriuretic peptide levels, a sign of worsening heart failure. CardioMEMS was initially approved for Class III heart failure in 2014. Class II heart failure is categorized as mild, with slight limitations in physical activity.
"Heart failure is a race against time where too often we’re behind because patients are not getting care early enough," Philip B. Adamson, M.D., chief medical officer of Abbott's heart failure business told the press. "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."
The expanded indication was supported by GUIDE-HF trial data showing Class II heart failure patients and those with elevated natriuretic peptide levels using CardioMEMS pulmonary pressure monitoring had a respective 34 percent and 25 percent reduction in heart failure hospitalizations, emergency visits, and death.
"As the number one cause for hospitalizations in people age 65 and over, heart failure is its own pandemic in the United States," said J. Thomas Heywood, M.D., director of Advanced Heart Failure and co-director of the Pulmonary Hypertension Program at Scripps Clinic. "Utilizing the CardioMEMS HF System to monitor for signs of worsening heart failure has been shown repeatedly to reduce hospitalizations for patients with later-stage heart disease. The new data provided by the GUIDE-HF study means we can extend these benefits to less sick patients. In the United States alone, this could have a positive impact for more than a million people suffering from heart failure."
The paperclip-sized CardioMEMS, placed in the pulmonary artery via a minimally invasive procedure, monitors pressure changes that indicate worsening heart failure. The sensor transits daily pressure readings to the clinical team so therapy changes can be made to prevent progression to later-stage heart failure.
It was specifically approved for Class II heart failure patients and those whose blood test results show elevated natriuretic peptide levels, a sign of worsening heart failure. CardioMEMS was initially approved for Class III heart failure in 2014. Class II heart failure is categorized as mild, with slight limitations in physical activity.
"Heart failure is a race against time where too often we’re behind because patients are not getting care early enough," Philip B. Adamson, M.D., chief medical officer of Abbott's heart failure business told the press. "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."
The expanded indication was supported by GUIDE-HF trial data showing Class II heart failure patients and those with elevated natriuretic peptide levels using CardioMEMS pulmonary pressure monitoring had a respective 34 percent and 25 percent reduction in heart failure hospitalizations, emergency visits, and death.
"As the number one cause for hospitalizations in people age 65 and over, heart failure is its own pandemic in the United States," said J. Thomas Heywood, M.D., director of Advanced Heart Failure and co-director of the Pulmonary Hypertension Program at Scripps Clinic. "Utilizing the CardioMEMS HF System to monitor for signs of worsening heart failure has been shown repeatedly to reduce hospitalizations for patients with later-stage heart disease. The new data provided by the GUIDE-HF study means we can extend these benefits to less sick patients. In the United States alone, this could have a positive impact for more than a million people suffering from heart failure."