The US Food and Drug Administration (FDA) recently approved a medical device that could bring new hope to patients suffering from rheumatoid arthritis (RA), a chronic autoimmune condition often difficult to treat with conventional medications. Unlike standard therapies, the device harnesses the brain and nervous system to suppress the uncontrolled inflammation responsible for the disease.
The SetPoint System is a small, inch-long implant surgically placed in the neck, wrapping around the vagus nerve, which is thought to be the longest nerve in the body. It delivers one minute of electrical stimulation per day, which research suggests can “reset” the immune system and reduce crippling inflammation. Unlike most RA drugs that suppress the immune system and increase infection risk, this device works by re-educating the body’s immune response.
Described on a recent episode of the American College of Rheumatology podcast as a “true paradigm shift” in RA treatment, the SetPoint implant moves away from decades of reliance on pharmaceuticals, from gold salts to biologics. The FDA had granted it breakthrough designation last year to accelerate development and approval. The device represents an early example of bioelectronic medicine, which aims to control inflammation—a key factor in conditions including diabetes, heart disease, and cancer.
Clinical trials are already exploring vagus nerve stimulation for inflammatory bowel disease in children, lupus, multiple sclerosis, and Crohn’s disease. In a yearlong randomized controlled trial involving 242 patients with a sham-treatment group, over half of participants using the implant alone achieved remission or experienced disease improvement. Joint pain and swelling decreased by 60% and 63%, respectively. However, the device’s long-term safety and effectiveness outside clinical trials remain unknown, and the FDA requires post-marketing monitoring. Experts warn that surgery for implants can carry a risk of serious infections resistant to antibiotics.
For Dawn Steiner, a 58-year-old speech pathologist and clinical trial participant, the implant has been transformative. Diagnosed with RA 15 years ago, she tried eight biologic drugs with limited success. “Before the implant, the doctor would ask where I was in terms of pain on a scale of one to 10, and I would say I was living a six or seven,” she said. “Now I’m about a two.”
The SetPoint device stems from decades of research led by Dr. Kevin J. Tracey, neurosurgeon and president of the Feinstein Institutes for Medical Research at Northwell Health. Tracey co-founded SetPoint Medical and now serves as an adviser. He describes the vagus nerve as an “on-off switch” for an overactive immune system. “The brain can turn off inflammation as long as the vagus nerve is intact,” he said. “It’s like a brake system in your car.”
Dr. David Chernoff, chief medical officer of SetPoint Medical, explained, “Drugs find a pathway that contributes to damaging joints in RA patients and try to block it. What we’re doing is completely different. We’re re-educating the immune system through the brain to behave differently.” He added, “we’re not blocking the ability to fight off infection.” Tracey noted that some inflammation is necessary for healing wounds, fighting infections, and tissue repair.
The device’s price has not been disclosed, but a spokeswoman said it is designed to last 10 years and could cost less than a year of certain RA medications.
Dr. Lou Bridges, chief of rheumatology at the Hospital for Special Surgery and NewYork-Presbyterian/Weill Cornell Medical Center, expressed cautious optimism. “It’s still early days. The proof will be in the pudding,” he said. “I’m hoping they are correct, and this is a revolutionary new way to treat RA without drugs and without side effects. But I’ve heard this story before.”
[With TOI inputs]
The SetPoint System is a small, inch-long implant surgically placed in the neck, wrapping around the vagus nerve, which is thought to be the longest nerve in the body. It delivers one minute of electrical stimulation per day, which research suggests can “reset” the immune system and reduce crippling inflammation. Unlike most RA drugs that suppress the immune system and increase infection risk, this device works by re-educating the body’s immune response.
Described on a recent episode of the American College of Rheumatology podcast as a “true paradigm shift” in RA treatment, the SetPoint implant moves away from decades of reliance on pharmaceuticals, from gold salts to biologics. The FDA had granted it breakthrough designation last year to accelerate development and approval. The device represents an early example of bioelectronic medicine, which aims to control inflammation—a key factor in conditions including diabetes, heart disease, and cancer.
Clinical trials are already exploring vagus nerve stimulation for inflammatory bowel disease in children, lupus, multiple sclerosis, and Crohn’s disease. In a yearlong randomized controlled trial involving 242 patients with a sham-treatment group, over half of participants using the implant alone achieved remission or experienced disease improvement. Joint pain and swelling decreased by 60% and 63%, respectively. However, the device’s long-term safety and effectiveness outside clinical trials remain unknown, and the FDA requires post-marketing monitoring. Experts warn that surgery for implants can carry a risk of serious infections resistant to antibiotics.
For Dawn Steiner, a 58-year-old speech pathologist and clinical trial participant, the implant has been transformative. Diagnosed with RA 15 years ago, she tried eight biologic drugs with limited success. “Before the implant, the doctor would ask where I was in terms of pain on a scale of one to 10, and I would say I was living a six or seven,” she said. “Now I’m about a two.”
The SetPoint device stems from decades of research led by Dr. Kevin J. Tracey, neurosurgeon and president of the Feinstein Institutes for Medical Research at Northwell Health. Tracey co-founded SetPoint Medical and now serves as an adviser. He describes the vagus nerve as an “on-off switch” for an overactive immune system. “The brain can turn off inflammation as long as the vagus nerve is intact,” he said. “It’s like a brake system in your car.”
Dr. David Chernoff, chief medical officer of SetPoint Medical, explained, “Drugs find a pathway that contributes to damaging joints in RA patients and try to block it. What we’re doing is completely different. We’re re-educating the immune system through the brain to behave differently.” He added, “we’re not blocking the ability to fight off infection.” Tracey noted that some inflammation is necessary for healing wounds, fighting infections, and tissue repair.
The device’s price has not been disclosed, but a spokeswoman said it is designed to last 10 years and could cost less than a year of certain RA medications.
Dr. Lou Bridges, chief of rheumatology at the Hospital for Special Surgery and NewYork-Presbyterian/Weill Cornell Medical Center, expressed cautious optimism. “It’s still early days. The proof will be in the pudding,” he said. “I’m hoping they are correct, and this is a revolutionary new way to treat RA without drugs and without side effects. But I’ve heard this story before.”
[With TOI inputs]
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