If your rheumatoid arthritis (RA) symptoms are bedeviling you and medication isn’t making enough of a difference, you may soon have a new option: a tiny device implanted in your neck that delivers a small zap of electricity to a critical nerve.
The U.S. Food and Drug Administration (FDA) approved the device, called the SetPoint System, for adults with moderate to severe rheumatoid arthritis symptoms who either can’t effectively manage their symptoms with biologics or targeted medications or can’t tolerate side effects from these drugs.
The SetPoint System delivers a brief, low-voltage jolt of electricity to the vagus nerve once a day to reduce the inflammation that exacerbates RA symptoms. The vagus nerve runs from the brain to the digestive tract and controls a wide variety of bodily functions, including immune responses.
The new device is welcome because existing medications have limitations, says S. Louis Bridges Jr., MD, PhD, a physician and the chief of rheumatology at the Hospital for Special Surgery and Weill Cornell Medical College in New York City.
“Most patients have a partial response to these drugs,” Dr. Bridges says. “In addition, even when there is a very good response, the medication sometimes loses its effectiveness over time.”
How Well Does the Neck Device Work?
A late-stage clinical trial of the SetPoint System involved 242 rheumatoid arthritis patients, all of whom had already tried at least one RA drug without getting the results they needed. Patients were randomly assigned to receive either the new device or join a control group with inactive devices.
Researchers measured what proportion of patients experienced at least a 20 percent improvement in symptoms with the device rather than the dummy implant.
After 12 weeks of treatment, 35 percent of patients who got the new device experienced at least a 20 percent improvement in symptoms, compared with 24 percent with the dummy implant, according to trial results reported by SetPoint Medical.
Over the next 12 weeks of the trial, every patient received an active implant, including the group that had originally received a dummy device. By the end of this portion of the trial, more than half of patients in both treatment groups experienced at least a 20 percent improvement in symptoms, according to the data reported by the company.
After one year of follow-up, 75 percent of patients no longer needed medication for rheumatoid arthritis, according to the company.
What Are the Side Effects and Long-Term Risks?
During the initial 12 weeks of the trial, 1.7 percent of patients experienced serious side effects — most often mild to moderate hoarseness due to vocal cord dysfunction associated with the implantation procedure, according to data reported by the company. There were no serious side effects during the second half of the trial, and no patients dropped out because of safety issues.
“There don’t appear to be significant short-term risks from the surgical implantation procedure,” Bridges says.
As for any potential long-term risks, Bridges cautions that data is lacking at this point.
“Any treatment, once approved, needs long-term studies to see how long the response lasts, and to look for any adverse effects that occur months to years after the treatment is started,” Bridges says.
Who Might Benefit Most From the New Neck Device?
Based on what’s currently known about the SetPoint System, it may appeal to many patients who are unable to use medications because of the risk of infections or other side effects, says Bruno Bonaz, MD, PhD, a professor emeritus and a member of the Grenoble Institute of Neurosciences at Grenoble Alpes University in France, who has extensively studied this technology.
“This could be an alternative therapy to medications in patients who don’t do well with medications, or patients who do not want medications, or as a primary treatment in patients free of any treatment,” Dr. Bonaz says.
When Will the Neck Device Be Available?
The SetPoint System will be available in some U.S. cities later this year, and nationwide in early 2026, the company said. No pricing information has yet been disclosed.
EDITORIAL SOURCES
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Resources
SetPoint Medical Receives FDA Approval for Novel Neuroimmune Modulation Therapy for Rheumatoid Arthritis. SetPoint. July 31, 2025.
SetPoint Medical Announces Late-Breaking Data from RESET-RA Study at ACR Convergence 2024. SetPoint. November 18, 2024.
Emily Kay Votruba has copyedited and fact-checked for national magazines, websites, and books since 1997, including Self, GQ, Gourmet, Golf Magazine,Outside, Cornell University Press, Penguin Random House, and Harper's Magazine. Her projects have included cookbooks (Padma Lakshmi's Tangy Tart Hot & Sweet), self-help and advice titles (Mika Brzezinski's Know Your Value: Women, Money, and Getting What You're Worth), memoirs (Larry King's My Remarkable Journey), and science (Now You See It: How the Brain Science of Attention Will Transform How We Live, Work, and Learn, by Cathy Davidson). She started freelancing for Everyday Health in 2016.
Lisa Rapaport is a journalist with more than 20 years of experience on the health beat as a writer and editor. She holds a master’s degree from the UC Berkeley Graduate School of Journalism and spent a year as a Knight-Wallace journalism fellow at the University of Michigan. Her work has appeared in dozens of local and national media outlets, including Reuters, Bloomberg, WNYC, The Washington Post,Los Angeles Times, Scientific American, San Jose Mercury News, Oakland Tribune, Huffington Post, Yahoo! News, The Sacramento Bee, and The Buffalo News.
