The FDA has approved revised instructions for use for a neuromodulation device for HF, incorporating long-term, postmarket data from the BeAT-HF randomized clinical trial. The device, Barostim, is indicated for patients with NYHA class III HF or class II with a recent history of class III, a left ventricular ejection fraction of 35% or less, and a NT-pro BNP level less than 1,600 pg/ml. The revised instructions now include primary endpoint results, symptomatic data, win ratio, and all-cause mortality data. CVRx Inc. CEO Nadim Yared expressed excitement over the FDA’s validation of the long-term results and the ability to share the data with physicians and patients.
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FDA approves updated instructions of use for implanted neuromodulation device for HF
