FDA Approved a Rheumatoid Arthritis Implant Used One Minute a Day
About 80% of patients who had not responded to drugs were significantly better a year after receiving it.
Science Friday · Is there science behind the ‘nervous system reset’?In summer 2025, the Food and Drug Administration approved an implant for rheumatoid arthritis that is switched on for one minute a day, said Kevin Tracey, a neurosurgeon who helped develop it.
In the study, Tracey said "about 80% of people with rheumatoid arthritis not responding to drug therapy" were significantly better one year after receiving the implant.
The device, made by Setpoint Medical, is "about the size of a multivitamin," Tracey said. It is placed on the nerve on the left side of the neck. The vagus nerve is a bundle of fibers that carries signals between the brain and the body, including the immune system.
Once implanted, the daily one-minute pulse turns on what Tracey calls the inflammatory reflex, the nerve circuit that instructs immune cells to make fewer inflammatory molecules. He likens that calming effect to using brakes to slow a moving car.
Seeing laboratory work reach patients has been moving for Tracey. He said patients have told him that they once had great trouble moving through daily life and now manage ordinary activities, with some saying they no longer take arthritis medication.
Researchers are still in the early stages of learning how widely the approach will help, and Tracey said results are expected to differ from person to person.
Questions people ask
What is rheumatoid arthritis, and why is it so hard to treat?
Rheumatoid arthritis is an autoimmune disease in which the immune system mistakenly attacks the joints, causing pain, swelling, and eventual joint damage. Common drugs calm the whole immune system, so they work only in about half of patients and can raise the risk of infection and other side effects.
What is the vagus nerve?
The vagus nerves are two long bundles of fibers that run from the base of the brain down through the neck and chest into the abdomen, with branches to the heart, lungs, and digestive organs. Each nerve contains about 100,000 fibers that carry separate signals in both directions, from the body to the brain and from the brain to the body.
Does the implant replace medication?
Some patients have told Tracey they no longer take medication and live normal lives. The measured study result is narrower: about 80% of patients who did not respond to drugs were significantly better one year after implantation, not that all stopped drugs.