FDA approves updated instructions of use for implanted neuromodulation device for HF

CVRx Inc. announced the FDA approved its revised instructions for use for its baroreflex activation therapy device incorporating clinical data from the BeAT-HF randomized clinical trial.
As Healio previously reported, in certain patients with HF with reduced ejection fraction, use of the device (Barostim) was associated with improved N-terminal pro-B-type natriuretic peptide levels, quality of life and functional outcomes.
The device is indicated for patients who have NYHA class III HF, or class II with a recent history of class III, despite treatment with guideline-directed medical therapies;

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