The FDA has expanded its approval for Abbott’s CardioMEMS cardiac sensor, allowing it to be used by a larger number of patients suffering from earlier stages of heart failure.
The paper-clip-sized implant remotely monitors changes in the blood pressure of the pulmonary artery, carrying blood from the heart to the lungs so it can pick up oxygen before being pumped out to the rest of the body.
Changes in this pressure can be an early sign of worsening heart failure. Abbott estimates the FDA’s green light will allow its system to be used by an additional 1.2 million patients in the U.S.—out of the more than 6.2 million people diagnosed with heart failure—enabling physicians to fine-tune their medication doses before the disease progresses to more serious stages.
"Heart failure is a race against time where too often we're behind because patients are not getting care early enough," Philip Adamson, M.D., chief medical officer of Abbott's heart failure business, said in a statement.
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The CardioMEMS device—which is placed within the pulmonary artery through a minimally invasive procedure—was first approved by the FDA in 2014 for use in patients who had been hospitalized with heart failure within the past year and were diagnosed with Class III disease on the New York Heart Association scale. Abbott added the implant to its portfolio through its 2017 acquisition of St. Jude Medical.
The new indication covers people living with Class II heart failure, with more mild symptoms such as fatigue and shortness of breath, as well as people with elevated levels of natriuretic peptide biomarkers confirmed by a blood test, which have been linked with a worsening condition.
A previous clinical trial of CardioMEMS showed that by changing the course of heart failure medications earlier, the data provided by the device were able to reduce the rate of hospitalizations by 28%.
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For patients facing the most serious cases of heart failure, Abbott has been providing its HeartMate 3 ventricular pump implant and has been working with its competitor Medtronic to make sure it's available to patients as an alternative since the medtech giant discontinued its troubled HeartWare device last year.
Medtronic’s HeartWare implant—designed as a bridge therapy for heart failure patients awaiting an organ transplant—had seen multiple recalls of the system following reports of multiple injuries and more than a dozen deaths after malfunctions during restarts of the device caused it to stop pumping.