PMA_MER  

DevicePMAs@therightstef:P180050_S000 / 43-49 JSONTXT

Approval for The BAROSTIM NEO System. The device is indicated for the improvement of symptoms of heart failure. quality of life, six-minute hall walk and functional status, for patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction <= 35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines.

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