The Food and Drug Administration has approved the Barostim Neo System, an electronic carotid sinus baroreceptor stimulator, for advanced heart failure patients who have a regular heart rhythm, an ejection fraction of 35% or less, and who are not candidates for cardiac resynchronization.
A tiny, unilateral electrode delivers a pulse that decreases sympathetic but increases parasympathetic tone. The effect is that blood vessels relax and production of stress hormones drops. The device is powered by a small generator implanted under the collarbone.
Approval was based on BeAT-HF, a randomized trial with 408 patients on guideline-directed medical therapy with left ventricular ejection fractions at or below 35% and New York Heart Association class III disease.
At 6 months, 125 patients implanted with the device had improved about 14 points more than controls on a quality of life scale, walked about 60 meters farther in 6 minutes, and were more likely to have improved a functional class or two. The benefits corresponded with a drop in the N-terminal of the prohormone brain natriuretic peptide.
Possible complications include infection, low blood pressure, nerve damage, arterial damage, heart failure exacerbation, stroke, and death. Contraindications include certain nervous system disorders, uncontrolled and symptomatic bradycardia, and atherosclerosis or ulcerative carotid plaques near the implant zone, the FDA said.
The system, from CRVx in Minneapolis, received priority review as a breakthrough device. The agency is requiring a phase 4 investigation of its potential to reduce hospitalizations and prolong life.