FDA Approves SetPoint Medical's Vagus Nerve Stimulation System for Rheumatoid Arthritis
SetPoint Medical has received FDA approval for its vagus nerve stimulation (VNS) system, specifically designed to treat rheumatoid arthritis. This approval marks a significant milestone as it is the first VNS device approved for this condition. The device, which is about the size of a jelly bean, is implanted on the vagus nerve in the neck and operates for approximately 60 seconds daily. The pivotal clinical trial, known as RESET-RA, involved 242 patients who had not responded to standard medications. Results showed that about 35% of these patients experienced a 20% improvement in symptoms after three months, compared to 24% in the sham group. 
