FDA Approves Experimental Device for Rheumatoid Arthritis Treatment: A Rebirth for Lynn Milam and Possible Turning Point in Autoimmune Disease Therapy
For over four years, Lynn Milam’s life was marred by the constant discomfort emanating from her swollen joints.
“My children couldn’t embrace me,” she recounts. “I couldn’t hold my husband’s hand.”
Even daily tasks like climbing stairs and helping raise their teenage son became impossible for Milam, who spent most days confined to the couch.
Her affliction was rheumatoid arthritis, a condition where the immune system mistakenly attacks the lining of joints.
Milam tried various treatments: physical therapy, acupuncture, steroids, and even the latest immunosuppressive drugs. Yet, she found no relief.
That changed in October 2023 when a surgeon implanted an experimental device in Milam’s neck. This device delivers brief electrical pulses to her vagus nerve, a crucial link between the brain and internal organs, for a minute each morning.
“Three weeks later, my elbow pain completely subsided,” she says. “Then my hands stopped hurting, and the swelling began to diminish.”
Eventually, all symptoms of rheumatoid arthritis vanished. Milam, now 60, claims her life with her husband has returned to normal.
“It’s like a rebirth,” she says.
Now, this device is set to benefit numerous individuals like Milam.
In July 2023, the Food and Drug Administration approved the device, manufactured by SetPoint Medical, for those with rheumatoid arthritis who do not respond adequately to medication.
On August 22, surgeons at New York’s Northwell Health implanted the first such approved device in a patient.
This FDA approval could mark a significant shift in the treatment of not just rheumatoid arthritis but also other autoimmune diseases, including multiple sclerosis and inflammatory bowel disease.
“This therapy taps into the body’s inherent mechanism for controlling inflammation,” says Dr. John Tesser, a rheumatologist in Phoenix who led the study culminating in the device’s approval.
By stimulating the vagus nerve, the device sends signals to the hypothalamus, a brain region regulating bodily functions and interacting with the immune system. In response, the hypothalamus sends messages down the vagus nerve to the spleen.
These signals instruct certain cells in the spleen to slow production of proteins called cytokines, which manage inflammation, including inflammation in joints. Although essential for fighting infection, these proteins can also harm healthy tissues, such as the lining of joints.
Though dramatic recoveries like Milam’s are uncommon, the pivotal clinical trial showed that patients who had not responded to even potent drugs often experienced significant improvements.
“Thirty-five percent of these hard-to-treat patients achieved meaningful improvement,” Tesser notes, significantly more than in a comparison group with inactive stimulators.
The implantation process is simple and straightforward for surgeons accustomed to vagus nerve stimulator procedures typically used to control epileptic seizures. Dr. Peter Konrad, chair of neurosurgery at the Rockefeller Neuroscience Institute at West Virginia University, explains:
“The device, the size of a lima bean, is contained within a small silicone jacket and powered by a chip.”
Post-surgery complications were minor for Milam. Her voice was initially limited to a whisper due to the device’s proximity to her vocal cords. A subsequent procedure resolved this issue but left her voice slightly lower than before. Nevertheless, Milam considers it an acceptable trade-off for a treatment that worked when medications failed.
The stimulator has enabled Milam to regain her ability to climb stairs, cook, and travel. It’s also facilitated shared experiences between her and her husband once again.
“Walking the dogs, holding hands—simple things,” says Donald Milam. “And embraces.”