Why A Neurosurgeon Treats Arthritis
The vagus nerve carries signals between the brain and the immune system. Brief stimulation of the nerve activates a natural pathway, sometimes called the inflammatory reflex, that turns down the production of inflammatory signals such as TNF and IL-6 by 30 to 70 percent while leaving normal immune defenses intact. This is the same nerve that has been stimulated safely for epilepsy since the 1980s.
The SetPoint System
The SetPoint System is the first FDA-approved device treatment for rheumatoid arthritis, and it is not the vagus nerve stimulator used for epilepsy. There is no chest generator and no lead. The whole device is a rechargeable stimulator about the size of a vitamin capsule, secured directly on the left vagus nerve in the neck through a single incision, in a 60 to 90 minute outpatient procedure under general anesthesia. Once your rheumatologist activates it, the device delivers one minute of stimulation automatically each day. You charge it for a few minutes each week with a collar worn over the neck. It is designed to last about ten years and is MRI-conditional.
Who May Be A Candidate
The approved indication, and the practical requirements, are:
- Adults with moderately to severely active rheumatoid arthritis.
- An inadequate response to, loss of response to, or intolerance of at least one biologic or JAK-inhibitor medication.
- No paralysis of the vocal cords and no reason surgery in the neck would be unsafe.
- Able to stop blood thinners for about a week before the procedure, if you take them.
What The Evidence Shows
Approval was based on RESET-RA, a randomized, sham-controlled, double-blind study of 242 patients at 41 centers in the United States, published in Nature Medicine in 2025. The device met its safety and effectiveness endpoints. The most common side effect was temporary hoarseness; through twelve months there were no device-related serious infections, cancers, or cardiac events. Three quarters of study patients were free of biologic and targeted-synthetic medications at twelve months.
Working With Your Rheumatologist
Your rheumatologist decides with you whether this treatment fits, refers you for the implant, and manages activation and follow-up. Dr. Bari performs the implant and sees you for surgical recovery. Your arthritis care otherwise stays with your rheumatologist.
Questions To Bring
- Have I had an inadequate response to at least one biologic or JAK inhibitor?
- What would the procedure and recovery involve?
- How would the device change my current medications?
- What side effects should I watch for?
