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FDA Expands Eligibility for Cardio MEMS Heart Failure System

FDA Expands Eligibility for Cardio MEMS Heart Failure System

 


The U.S. Food and Drug Administration (FDA) has expanded Abbott’s CardioMEMS indications heart failure According to the company, the (HF) system will target an additional 1.2 million patients in the United States with implantable HF sensors.

The CardioMEMS HF system remotely monitors changes in pulmonary arterial pressure and warns of early deterioration of HF.

In 2014, the FDA first approved the system for use with New York Heart Association (NYHA) Class III HF and previous year’s HF inpatients.

The new indication allows the use of the CardioMEMS sensor in patients with NYHA class II HF, and in patients with HF exacerbations determined by elevated natriuretic peptides.

At one company, Philip B. Adamson, MD, Chief Medical Officer for Abbott’s Heart Failure Business, said, “Heart failure is a battle against time that is too late because patients are not being treated early enough. “. news release..

“This expanded indication means that doctors can treat more people with early-stage heart failure, prevent further distress, and possibly late progression that can have a serious impact on a person’s quality of life. We offer the opportunity to avoid, “says Adamson.

Result of Guide-HF Trial Abbott said he supported the expanded indications.

After adjusting for the effects of COVID-19, HF hospitalization and emergency visits were 34% each in both Class II HF patients using the CardioMEMS HF monitoring system and patients with elevated natriuretic peptide compared to conventional HF management. It decreased by 25%. , And death, the company reports.

The results of GUIDE-HF were presented at the European Society of Cardiology (ESC) in August 2021 and at the same time. LancetAnd reported by theheart.org | Medscape Cardiology At that time.

“Heart failure is a pandemic in the United States as the number one cause of hospitalization for people over the age of 65,” said the director of severe heart failure. Pulmonary hypertension The program at the Scripps Clinic in La Jolla, California is described in a news release.

“By using the CardioMEMSHF system to monitor for signs of exacerbation of heart failure, it has been repeatedly shown to reduce hospitalization for patients with late-stage heart disease,” Heywood says.

“The new data provided by the GUIDE-HF study means that these benefits can be extended to less ill patients. In the United States alone, this has a positive impact on more than one million people suffering from heart failure. It’s possible, “he adds.

Sources

1/ https://Google.com/

2/ https://www.medscape.com/viewarticle/969004

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