FDA Approves Implant Targeting Rheumatoid Arthritis Through Nerve Stimulation

FDA Approves Implant Targeting Rheumatoid Arthritis Through Nerve Stimulation
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The U.S. Food and Drug Administration has approved a new implantable device aimed at treating rheumatoid arthritis (RA), offering hope to patients for whom traditional medications have failed. The SetPoint System, reported by The New York Times, represents a new approach by stimulating the vagus nerve to reduce inflammation—a key factor in autoimmune diseases like RA.

The inch-long device is surgically implanted in the neck and sends daily one-minute electrical impulses to the vagus nerve, which is believed to regulate the immune response. Clinical trials involving 242 patients showed that over half of those using the device alone experienced remission or significant reduction in symptoms, with joint pain and swelling reduced by over 60%.

Unlike immunosuppressive drugs, the SetPoint device does not compromise the immune system. However, experts caution that, as with any surgical implant, infection risks exist. The device has been designated as a “breakthrough” technology by the FDA, accelerating its approval.

SetPoint’s long-term efficacy remains under observation, and further trials are underway for its use in other inflammatory conditions. While pricing has not been disclosed, it is expected to be less expensive than annual biologic drug treatments. Experts stress that further research is needed to confirm its sustained benefits.