FDA grants approval for expanded indication of heart failure sensor
pharmafile | February 22, 2022 | News story | Manufacturing and Production |
The FDA has granted approval for an expanded indication of Abbott’s CardioMEMS HF System, a small implantable sensor that can flag up early warning signs of worsening heart failure. With the expanded indication, an additional 1.2 million US patients are now eligible to benefit from advanced monitoring with the sensor.
The sensor was initially approved in 2014 for use in New York Heart Association (NYHA) Class III heart failure patients who were previously hospitalised due to heart failure within the last year.
The CardioMEMS sensor provides an early warning system enabling doctors to protect against worsening heart failure. It is a paperclip-sized device that is placed in the pulmonary artery during a minimally invasive procedure. From here, CardioMEMS monitors for pressure changes that indicate worsening heart failure, and wirelessly transmits daily pressure readings to a patient’s clinical team.
More than 6.2 million Americans have heart failure, with diagnoses projected to double by 2030. The technology allows physicians to make therapy changes, to combat progression to later-stage heart failure, while also empowering the patient to manage their condition from virtually anywhere.
“As the number one cause for hospitalisations in people age 65 and over, heart failure is its own pandemic in the USA,” said J Thomas Heywood, director of Advanced Heart Failure and co-director of the Pulmonary Hypertension Program at Scripps Clinic, La Jolla, USA. “Utilising the CardioMEMS HF system to monitor for signs of worsening heart failure has been shown repeatedly to reduce hospitalisations for patients with later-stage heart disease.”
“Heart failure is a race against time where too often we’re behind because patients are not getting care early enough,” said Philip B Adamson, MD, chief medical officer of Abbott’s heart failure business. “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.”
Ana Ovey
