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 long-term clinical post-marketing data from the manufacturer’s CVRx Inc.’s randomized BeAT-HF clinical study, the company announced.
The updated labeling for Barostim now states that the device is indicated for patients with New York Heart Association class III or II heart failure who have recently experienced a class III exacerbation despite treatment with guideline-directed medical therapies (medications and devices) and who have a left ventricular ejection fraction (LVEF) ≤ 35% and a N-terminal pro-B-type natriuretic peptide level < 1600 pg/ml. The Barostim Neuromodulation System resembles a standard pacemaker with an electrode system, but it stimulates the baroreceptors of the carotid artery. The pulse generator is typically implanted subcutaneously below the left or right clavicle, with the electrode positioned at the adjacent carotid sinus. Barostim was originally approved in 2019 for adults with medically refractory advanced heart failure and LVEF ≤ 35% who are not good candidates for other device therapies, as reported by theheart.org | Medscape Cardiology. The approval was based on the results of the BeAT-HF study, which showed that neuromodulation therapy with Barostim led to functional improvements and improved quality-of-life measures. "We are thrilled to receive this important validation of the long-term results of the post-market phase of the BeAT-HF clinical study by the FDA and are excited to now share this data with physicians and patients," said Nadim Yared, President and CEO of CVRx, in a statement.