FDA Expands Label for CVRx Barostim System in HF
The US Food and Drug Administration (FDA) has approved an expanded label for the Barostim neuromodulation system in patients with heart failure (HF) that incorporates longer-term, postmarketing clinical data from the BeAT-HF randomized clinical trial, the manufacturer, CVRx Inc, has announced.
The updated labeling for Barostim now states that the device is indicated for patients with New York Heart Association class III or class II HF with a recent history of class III disease despite treatment with guideline-directed medical therapies (medications and devices), and who have left ventricular ejection fraction (LVEF) ≤ 35% and an N-terminal pro B-type natriuretic peptide level < 1600 pg/mL.
The Barostim neuromodulation system resembles a standard pacemaker with a lead system but stimulates carotid baroreceptors. The pulse generator is typically implanted subcutaneously below the left or right collarbone, with the lead positioned at the adjacent carotid sinus.
Barostim was originally approved in 2019 for adults with medically refractory advanced HF and LVEF ≤ 35% who aren’t good candidates for other device therapies, as reported by theheart.org | Medscape Cardiology.
The approval was based on results of the BeAT-HF trial, which showed that neuromodulation therapy using Barostim led to functional gains and improved quality-of-life measures.
“We are very pleased to receive this important validation from FDA of the long-term results of the post-market phase of the BeAT-HF clinical trial and excited we can now share this data with physicians and patients,” CVRx president and CEO Nadim Yared said in a statement.
