Abbott’s implantable cardiac monitor CardioMEMS lands expanded FDA designation

Abbott’s implantable cardiac sensor system CardioMEMS landed an expanded FDA clearance, allowing earlier stage heart failure patients to use the tech. 

The system, which is designed to monitor pressure changes in the heart, is implanted in a patient’s pulmonary artery during a minimally invasive procedure. The connected sensor is able to send data daily to doctors and care teams about a patient’s pressure readings. Doctors can also get alerts if a patient’s condition is worsening.

In 2014, Abbott got FDA clearance for CardioMEMS to be used on New York Heart Association (NYHA) Class III heart failure patients with a history of failure hospitalization. Today’s news opens up the sensor for use in Class II heart failure patients, as well as individuals with elevated natriuretic peptides. 

Abbott sought the expanded clearance using data from the GUIDE-HF trial, which includes roughly 3,600 participants across 140 North American sites. The randomized study includes patients with Class II to Class IV heart failure, as well as patients with elevated natriuretic peptides. The study, which began in 2018, is expected to complete in 2024. 

WHY IT MATTERS 

The CDC reports that 659,000 individuals in the US die every year from heart disease. 

Risk factors for heart disease include diabetes, obesity, an unhealthy diet, physical inactivity and excessive alcohol use, according to the agency. 

Abbott is pitching this technology as a way to remotely monitor patients with less severe heart disease. 

THE LARGER TREND

Cardiac monitoring is becoming increasingly connected. Abbott has a history in this space. In 2020, the company landed FDA clearance for part of its connected cardioverter defibrillator and cardiac resynchronization therapy defibrillator. The company got FDA clearance in 2017 for its Confirm Rx Insertable Cardiac Monitor (ICM), which tracks patients’ heart rhythms and sends the data to a smartphone app via Bluetooth. 

Consumer-focused companies have also released a slew of cardiac-focused tools. Apple’s Series 4 Apple Watch scored an FDA De Novo for its ECG capabilities. Fitbit later attained a clearance for its Fitbit Sense smartwatch to monitor heart rate and detect atrial fibrillation.

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