Abbott’s implantable cardiac monitor CardioMEMS lands expanded FDA designation


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Abbott’s implantable cardiac sensor system CardioMEMS landed an expanded FDA clearance, permitting earlier stage coronary heart failure sufferers to make use of the tech. 

The system, which is designed to observe strain modifications within the coronary heart, is implanted in a affected person’s pulmonary artery throughout a minimally invasive process. The related sensor is ready to ship information every day to docs and care groups a few affected person’s strain readings. Docs may get alerts if a affected person’s situation is worsening.

In 2014, Abbott bought FDA clearance for CardioMEMS for use on New York Coronary heart Affiliation (NYHA) Class III coronary heart failure sufferers with a historical past of failure hospitalization. At present’s information opens up the sensor to be used in Class II coronary heart failure sufferers, in addition to people with elevated natriuretic peptides. 

Abbott sought the expanded clearance utilizing information from the GUIDE-HF trial, which incorporates roughly 3,600 members throughout 140 North American websites. The randomized research consists of sufferers with Class II to Class IV coronary heart failure, in addition to sufferers with elevated natriuretic peptides. The research, which started in 2018, is predicted to finish in 2024. 


The CDC reviews that 659,000 people within the US die yearly from coronary heart illness. 

Danger elements for coronary heart illness embrace diabetes, weight problems, an unhealthy weight loss plan, bodily inactivity and extreme alcohol use, in response to the company. 

Abbott is pitching this know-how as a technique to remotely monitor sufferers with much less extreme coronary heart illness. 


Cardiac monitoring is changing into more and more related. Abbott has a historical past on this house. In 2020, the corporate landed FDA clearance for a part of its related cardioverter defibrillator and cardiac resynchronization remedy defibrillator. The corporate bought FDA clearance in 2017 for its Verify Rx Insertable Cardiac Monitor (ICM), which tracks sufferers’ coronary heart rhythms and sends the info to a smartphone app by way of Bluetooth. 

Shopper-focused firms have additionally launched a slew of cardiac-focused instruments. Apple’s Collection 4 Apple Watch scored an FDA De Novo for its ECG capabilities. Fitbit later attained a clearance for its Fitbit Sense smartwatch to observe coronary heart charge and detect atrial fibrillation.

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