SetPoint Medical, a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases, announced that the first patient has been treated with the SetPoint System at Beth Israel Deaconess Medical Center (BIDMC) in Boston. The procedure was performed by Joshua P. Aronson, M.D., functional neurosurgeon at BIDMC.
The SetPoint System is the first-and-only U.S. Food and Drug Administration (FDA)-approved neuroimmune modulation therapy for adults living with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response, loss of response, or intolerance to one or more biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs). The system includes a small, implantable neurostimulator that delivers targeted stimulation to the left vagus nerve, activating the body's innate anti-inflammatory pathways that help regulate the immune activity associated with RA.
"The SetPoint System reflects a significant evolution in neuromodulation, applying a targeted, device-based approach to a disease that has long been treated pharmacologically," said Dr. Aronson. "An outpatient procedure now opens a fundamentally different treatment pathway for patients with rheumatoid arthritis."
More than 1.5 million Americans live with RA, a chronic autoimmune disease in which the immune system attacks healthy tissue, causing joint pain, bone erosion, deformity, reduced mobility and long-term disability. There is no cure, and many patients do not achieve or sustain adequate disease control with existing DMARD therapies.
"Treating the first patient in Boston with the SetPoint System marks an exciting milestone for people living with rheumatoid arthritis and for our clinical community," said Brian J. Stout, M.D., rheumatologist at BIDMC. "Neuroimmune modulation offers a different mechanism of action for patients whose disease is not managed with initial biological agents. Being able to offer an alternative to immunosuppressives with a different mechanism expands the treatment options we have for managing RA."
