FDA Clears Device to Help Rheumatoid Arthritis Sufferers

The FDA has approved a new device aimed at helping people with rheumatoid arthritis, a chronic autoimmune disorder affecting about 1.5 million Americans. The SetPoint System, about an inch long, is surgically implanted in the neck to stimulate the vagus nerve for one minute each day, reports the New York Times. Patients can recharge the device wirelessly once it's implanted, per MedPage Today. Proponents say this approach—using electrical signals to "reset" the immune system—marks a significant departure from the standard drug-based treatments, which often suppress immune function and come with notable side effects.

In a clinical trial involving 242 patients, more than half of those using the implant alone either went into remission or saw significant improvement in their condition, with joint pain and swelling dropping by at least 60%, per the Times. The most common serious complication was hoarseness from surgery, reported in less than 2% of cases. Experts caution that, as with other implants, there's a risk of serious infection. The device's long-term safety and effectiveness outside controlled studies remain uncertain, and the FDA is requiring ongoing patient monitoring.

Patient testimonials have so far been positive. Dawn Steiner, a speech pathologist who'd tried multiple medications over 15 years, described the implant as life-changing, reporting far less pain and increased mobility without being immunocompromised. Researchers are also testing vagus nerve stimulation for other inflammatory diseases, including lupus and inflammatory bowel disease.

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The SetPoint device is the result of decades of research led by Dr. Kevin J. Tracey, who likens the vagus nerve to "an on-off switch" for a too-active immune system. While the price hasn't been disclosed, the company says it should last a decade and cost less than a year's supply of some current drugs used to treat rheumatoid arthritis. Still, questions remain about whether benefits will hold up over time—a point even optimistic experts admit will require further study.