For over four years, Lynn Milam endured the debilitating pain caused by rheumatoid arthritis, a condition that severely impacted her daily life and relationships. “My children could not hug me,” Milam recalls. “I couldn't hold my husband's hand, climb stairs, or even assist in raising my teenage son.” Most days were spent confined to the couch, struggling with the relentless discomfort that characterized her condition. Rheumatoid arthritis occurs when the body’s immune system mistakenly attacks the lining of the joints, leading to chronic inflammation and pain.
Milam explored various treatment options in her fight against rheumatoid arthritis. She tried everything from physical therapy and acupuncture to steroids and the latest immune-modulating drugs. Unfortunately, nothing provided the relief she desperately sought. However, her life took a dramatic turn in October 2023 when a surgeon implanted an experimental device in her neck.
This innovative device delivers short pulses of electricity to the vagus nerve for one minute each morning. The vagus nerve is a crucial pathway that connects the brain to various internal organs. Just three weeks after the procedure, Milam reported a significant reduction in her pain levels. “My elbow pain was completely gone,” she said. “Then my hands didn't hurt anymore, and the swelling started to subside. Eventually, all symptoms of rheumatoid arthritis vanished.” At 60 years old, Milam feels as though she has experienced a rebirth, reclaiming the life she enjoyed before illness.
In July 2023, the Food and Drug Administration (FDA) approved this groundbreaking device, developed by SetPoint Medical, for individuals suffering from rheumatoid arthritis whose symptoms are not sufficiently controlled by traditional medications. On August 22, surgeons at Northwell Health in New York successfully implanted the first approved device in a patient, marking a significant milestone in the treatment of autoimmune diseases.
Dr. John Tesser, a rheumatologist in Phoenix who oversaw the study leading to the device's approval, highlighted its innovative approach: “This treatment utilizes the body's own mechanisms for managing inflammation.” By stimulating the vagus nerve, the device communicates with the hypothalamus, a brain region that plays a vital role in regulating bodily functions and immune responses. The hypothalamus then sends signals back down the vagus nerve to the spleen, instructing it to reduce the production of cytokines, proteins that regulate inflammation. While cytokines are essential for combating infections, excessive levels can harm healthy tissues, including joints.
Although the device does not guarantee dramatic recoveries like Milam's, the pivotal clinical trial showed promising results. Dr. Tesser noted that 35% of patients who had previously not responded to even the strongest treatments experienced significant improvement. This outcome was markedly better than that of a comparison group whose stimulators had not yet been activated.
The entire implantation process involves a device roughly the size of a lima bean, as described by Dr. Peter Konrad, chair of neurosurgery at the Rockefeller Neuroscience Institute. The device is compact and encased in a silicone jacket, making it suitable for outpatient surgery. “It’s straightforward for any surgeon experienced in implanting vagus nerve stimulators, which are commonly used for controlling seizures,” Konrad explained. Milam herself noted, “I've had dental surgery that was more of a process than this surgery.”
However, Milam's recovery was not entirely without challenges. As the device was positioned close to her vocal cords, her voice was temporarily limited to a whisper. A subsequent procedure corrected this issue but left her with a slightly altered voice. “I’ll accept that for a treatment that achieved what drugs couldn’t,” she said.
The stimulator has enabled Milam to reclaim her ability to climb stairs, cook, and travel once again. Her husband, Donald Milam, expressed the joy of being able to share simple activities with his wife. “Walking the dogs, holding hands—just the simple things,” he said. Through this groundbreaking treatment, Milam and her family are experiencing a renewed sense of hope and normalcy.