FDA Expands Label for CVRx Barostim System in HF

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The FDA has approved an expanded label for the Barostim neuromodulation system for patients with heart failure, based on longer-term clinical data from the BeAT-HF trial. The system is indicated for patients with class III or II heart failure with certain criteria. The device stimulates carotid baroreceptors and is implanted below the collarbone. The FDA’s approval was based on the BeAT-HF trial, which showed functional gains and improved quality of life with Barostim. CVRx president Nadim Yared expressed excitement over sharing the data with physicians and patients.

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