In July, the Food and Drug Administration approved the device, made by SetPoint Medical, for people with rheumatoid arthritis whose symptoms aren't adequately controlled by drugs.
On Aug. 22, surgeons at Northwell Health in New York implanted the first approved device in a patient.
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The FDA approval could be a turning point for the treatment of not only rheumatoid arthritis, but other autoimmune diseases, including multiple sclerosis and inflammatory bowel disease.
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By stimulating the vagus nerve, the device sends a signal to the hypothalamus, a brain area that regulates bodily functions and interacts with the immune system. That brain area responds by sending signals back down the vagus nerve to the spleen.
The signals instruct certain cells in the spleen to slow down production of proteins called cytokines, which regulate inflammation, including inflammation in the joints. Cytokines play an important role in fighting infection, but can also trigger damage to healthy tissues, including the lining of joints.
The device rarely produces the sort of dramatic recovery that Lynn Milam experienced. But the pivotal clinical trial found that patients who had not responded to even the most powerful drugs often saw meaningful improvement.
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After the surgery, though, there was a hitch.
Because the device sits so close to the vocal cords, Milam's voice was temporarily limited to a whisper. A second procedure fixed that but left her voice slightly lower than it had been.