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Vagus Nerve Device OK'd for Rheumatoid Arthritis

UNITED STATES, JUL 31 – The Setpoint System reduces inflammation by stimulating the vagus nerve, with 35.2% of treated patients achieving significant symptom improvement in clinical trials.

  • The US Food and Drug Administration approved the SetPoint System, the first vagus nerve stimulation device for rheumatoid arthritis patients who haven't responded to or can't tolerate biologic or targeted synthetic DMARDs.
  • Nearly 75% of rheumatoid arthritis patients express dissatisfaction with current therapies and have discontinued them due to adverse side effects, while treatment involves strong anti-inflammatory medications increasing infection and cancer risks.
  • In clinical trials, 242 participants with RA showed about 35% experienced symptom reduction versus 24% in the placebo group, with less than 2% facing serious adverse events.
  • SetPoint plans to start commercialization in certain US cities this year, with a broader US expansion expected in early 2026.
  • This approval marks the first time a device like this has been authorized for an autoimmune disorder, opening possibilities for treating inflammation-related conditions such as heart failure, diabetes, and neurodegenerative disorders.
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The Food and Drug Administration (FDA) approved on Wednesday a medical device that offers new hope to patients disabled by rheumatoid arthritis, a chronic condition that affects 1.5 million Americans and is often resistant to treatment. The condition is usually controlled by medications. The device represents a radical deviation from standard care, taking advantage of the power of the brain and nervous system to placate uncontrolled inflammation…

SetPoint is an innovative implant that stimulates the vagus nerve to block inflammation and paves the way for a new era in bioelectronic medicine

·New York, United States
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Medscape broke the news in United States on Thursday, July 31, 2025.
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