Abbott’s wireless, paperclip-sized cardiac sensor has received the blessing of Britain’s National Institute for Health and Care Excellence (NICE), paving the way for coverage of the device in England’s National Health Service (NHS).
In final guidance published Feb. 5, the cost-effectiveness watchdog recommended the company’s CardioMEMS HF System for adults with later-stage heart failure who have been previously hospitalized for the condition and are at risk of future admission.
The agency, which decides the drugs and medical technology that should be paid for by the taxpayer-funded NHS, said it based its decision on evidence from three randomized controlled trials showing the device could lower heart failure hospitalizations by about one-third.
“By enabling early detection of problems and timely medication adjustments, [the sensor] has the potential to reduce emergency hospital admissions and help people manage their condition more effectively from the comfort of their own home,” Anastasia Chalkidou, M.D., Ph.D., NICE’s healthtech program director, said in a news release.
The sensor is implanted in the pulmonary artery through a minimally invasive procedure. Once implanted, it remotely monitors changes in pulmonary artery pressure, which can be an early sign of worsening heart failure.
Patients lie on a special pillow and press a button to take the readings, which are sent wirelessly to their healthcare providers, who can adjust their medication before the disease progresses.
Chalkidou said the technology can help patients avoid trips to the emergency room while helping the NHS manage “a condition that places significant demands on hospital resources.”
According to NICE, nearly 920,000 people in the U.K. are affected by chronic heart failure, and the condition costs the NHS around 2 billion pounds sterling annually. It accounts for roughly a million hospital bed days each year, according to the agency.
The NICE guidance limits its recommendation to patients with New York Heart Association class 3 chronic heart failure, which is marked by fatigue, palpitations and shortness of breath during minimal physical activity.
The sensor received expanded FDA approval in the U.S. in 2022 for patients suffering from class 2 heart failure, which causes milder symptoms. The FDA first approved the implant for class 3 heart failure patients in 2014.
