Abbott implantable heart failure monitor gains expanded FDA approval
Abbott has received an expanded FDA approval for its CardioMEMs HF System, making the solution available for patients in earlier stages of heart failure (HF).
The solution was originally approved by the FDA for New York Heart Association (NYHA) Class III HF patients with a prior HF hospitalization. It is now also available for patients with NYHA Class II HF or those who have submitted blood tests showing elevated natriuretic peptide levels.
The company estimates that this expanded approval means 1.2 million additional patients in the United States now have access to the CardioMEMS system. It is a small, paperclip-sized device that is placed in the pulmonary artery to track pressure changes through a remote monitoring system. Clinicians receive daily updates from the device, allowing them to adjust treatment if there are any signs detected of worsening HF.
“Heart failure is a race against time where too often we're behind because patients are not getting care early enough,” Philip B. Adamson, MD, chief medical officer of Abbott's heart failure business, said in a prepared statement. “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 FDA reviewed early findings from the GUIDE-HF trial to make its decision. That study has enrolled 3,600 patients to test the safety and effectiveness of the CardioMEMS system on new patient populations
“As the number one cause for hospitalizations in people age 65 and over, heart failure is its own pandemic in the United States,” Thomas Heywood, MD, director of advanced heart failure and co-director of the Pulmonary Hypertension Clinic at Scripps Clinic in La Jolla, California, said in the same statement. “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.”
Related Heart Failure Content:
Empagliflozin helps heart failure patients stay out of the hospital
Implantable atrial shunt therapy trial identifies treatable HFpEF patients
Heart failure associated with an increased risk of cancer
Tafamidis boosts survival for patients with transthyretin amyloid cardiomyopathy
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.