Cardiac Dimensions’ Device Reduces Heart Failure In Trial
Results of the 120-patient, sham-controlled REDUCE FMR trial showed Cardiac Dimensions Carillon device can significantly reduce mitral regurgitation and left ventricular volume in patients with symptomatic functional mitral regurgitation.
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In a new draft National Coverage Determination, the US Medicare agency proposes extending coverage of transcatheter mitral valve repair to certain patients with functional mitral regurgitation.
The double-blind CARILLON trial will compare mechanical repair of functional mitral valve regurgitation with medical therapy alone in 400 patients at about 50 sites. The company is already running the REDUCE FMR randomized trial outside the US.
The American Medical Association has written a set of principles for augmented intelligence (AI) development and deployment in health care. The organization hopes these principles can shape “a consistent governance structure for advancements in health care technology.”