The FDA has approved SetPoint Medical’s vagus nerve stimulation (VNS) device for moderate-to-severe rheumatoid arthritis (RA) in patients failing or intolerant to biologic or targeted synthetic DMARDs.
This is the first neuromodulatory device of its kind for RA, representing a new therapeutic class for refractory cases.
Approval was based on a double-blind, sham-controlled trial (n=242) showing statistically significant improvement in ACR20 response rates and reduced DMARD dependency at one year.
The device’s mechanism leverages the anti-inflammatory properties of the vagus nerve, opening new avenues for immunomodulation in systemic autoimmune disease.
Clinical Background and Disease Burden
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