From smithsonianmag.com
The FDA just approved the SetPoint System, which electrically stimulates the vagus nerve to control inflammation from the chronic disease
For years, rheumatoid arthritis (RA)—an autoimmune disease that causes inflammation—has often been resistant to treatment. About 1.5 million Americans have the chronic condition, which commonly leads to joint stiffness and pain. So far, to treat the disease, patients have been forced to rely on expensive immunosuppressant drugs that leave them at a higher risk for infections.
But now, a revolutionary new device could transform RA care. In late July, the United States Food and Drug Administration approved an implant that uses electrical signals to control inflammation by tapping into the vagus nerve—a pair of nerves that connect the brain with important internal organs. The move marks the first time an electrical therapy has been approved for the treatment of any autoimmune disease, reports New Scientist’s Grace Wade.
Kevin Tracey, a neurosurgeon and CEO of the Feinstein Institutes for Medical Research at Northwell Health, told NPR’s Jon Hamilton in February that the team first discovered the potential of using the vagus nerve to treat bodily inflammation by accident.
The researchers were experimenting on rats to see if a drug could prevent inflammation in the brain, when they realized the vagus nerve could also help suppress inflammation throughout the body.
With RA, the immune system becomes overactive and attacks the lining of joints, causing the disease’s symptoms. But the vagus nerve, the team realized, is like an “on-off switch” for the immune system’s extra activity, or “like a brake system in your car,” Tracey tells the New York Times’ Roni Caryn Rabin.
That discovery was 20 years ago. Now, after decades of deeper research, a team of scientists spearheaded by Tracey has finalized the SetPoint System: a chip about an inch long that’s surgically implanted into a patient’s neck, where it electrically stimulates the vagus nerve for one minute each day. A SetPoint spokeswoman tells the New York Times that the device will cost less than a year’s worth of some current RA treatments, and it can last a patient up to ten years.
By stimulating the vagus nerve, the implant can “control inflammation at its source, offering a safer, more effective treatment without the need to suppress the immune system,” Tracey says in a statement—a radical shift from traditional RA treatments.
The scientists conducted a year-long trial of the device with 242 RA patients. The results, released in 2024, revealed that more than half of the study’s participants using the implant saw a significant recession of their RA or achieved remission, according to the New York Times.
“Before the implant, the doctor would ask where I was in terms of pain on a scale of one to ten, and I would say I was living a six or seven,” Dawn Steiner, who participated in the trial, tells the New York Times. “Now I’m about a two.”
Less than 2 percent of patients experienced severe side effects, which involved hoarseness associated with the surgery.
The FDA was able to expedite the approval of SetPoint by designating it as a breakthrough. However, Aaron Kesselheim, a professor of medicine at Harvard Medical School who was not involved with the device, tells the New York Times that historically, drugs expedited by the agency often require updated safety labels after they are used by the wider public.
Although the researchers’ results may be promising, the long-term efficacy and safety of SetPoint is still unknown outside of clinical trials. The device is intended to be rolled out in certain U.S. cities this year, and expanded across more of the country in early 2026.
Implanted vagus nerve stimulators have already been approved for treat epilepsy and depression in some patients, per NPR. Next, SetPoint Medical, a company co-founded by Tracey, hopes to build on the potential of vagus nerve-based treatments to address other autoimmune diseases.
Vagus nerve stimulation is now being tested in clinical trials to manage lupus, inflammatory bowel disease and multiple sclerosis. One day, the technique might be able to treat other inflammation-related conditions, from diabetes to heart disease or Parkinson’s, as Stavros Zanos of the Feinstein Institutes for Medical Research, tells New Scientist.
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