Abbott's CardioMEMS HF System Scores FDA Nod For Earlier-Stage Heart Failure

The FDA has approved an expanded indication for Abbott Laboratories' ABT CardioMEMS HF System. 

• The CardioMEMS HF System was initially approved in 2014 for use in New York Heart Association (NYHA) Class III heart failure patients with a prior heart failure hospitalization within the last year. 
• The new indication allows the CardioMEMS sensor to be used by people living with Class II heart failure and for patients who undergo a blood test showing elevated biomarkers (natriuretic peptides), which indicate worsening heart failure.
• The sensor provides an early warning system enabling doctors to protect against worsening heart failure.
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• The CardioMEMS sensor is a paperclip-sized device that monitors for pressure changes that indicate worsening heart failure once placed in the pulmonary artery.
• GUIDE-HF trial data supported the CardioMEMS HF System's expanded indication. 
• 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.
• Class II heart failure is generally categorized as mild heart failure where patients have a slight limitation with physical activity. 
• Price Action: ABT shares closed 0.63% lower at $116.05 during after-hours trading on Friday.