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 funds will support expanded commercialization of the company’s baroreflex activation stimulation technology to treat heart failure in patients with a low left-ventricular ejection fraction.
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An overview of the global medical device approvals in September, as captured by Medtech Insight's Approvals Tracker. Approvals of several major cardiovascular devices highlighted what was otherwise a slow month for medical device approvals.