FDA Approves CVRx’s Barostim Neo For Heart Failure On Expedited Pathway

The PMA approval is based on the results of the BeAT HF trial, which showed that baroflex activation therapy with Barostim Neo safely improves quality-of-life scores and exercise capacity in patients with heart failure and reduced ejection fraction.

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The US Food and Drug Administration approved an original PMA for CVRx Inc.’s Barostim Neo baroreflex activation therapy device to treat heart failure based on results from the BeAT HF trial.

Barostim Neo is a pulse generator implanted below the collar bone and a lead connected to the carotid artery. It...

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