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BioWorld - Monday, December 22, 2025
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Home » FDA expands Abbott’s Cardiomems system for class II heart failure patients
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FDA expands Abbott’s Cardiomems system for class II heart failure patients

Feb. 22, 2022
By Catherine Longworth
Abbott Laboratories’ Cardiomems heart failure (HF) system is open to a larger patient population following an expanded approval from the FDA. Abbott’s system had previously been approved for class III HF patients that had been hospitalized for HF in the past year. A new expanded indication enables the sensor to be utilized by class II (earlier stage) HF patients and those whose blood test show elevated levels of biomarkers known as natriuretic peptides. The FDA based the approval on findings from the GUIDE-HF trial, which suggested class II HF patients and patients with elevated natriuretic peptides had better outcomes when their therapy was guided by pulmonary pressure monitoring, with a 34% and 25% reduction in heart failure hospitalizations and emergency visits, respectively, based on study data adjusted for the impact of COVID-19.
BioWorld MedTech Regulatory Cardiovascular U.S. 510(k) FDA

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