Vagus Nerve Device Approved for Rheumatoid Arthritis

The FDA has approved the first electrical implant therapy for rheumatoid arthritis (RA), offering new hope for patients who don’t respond to medications like biologics or JAK inhibitors.

The device uses vagus nerve stimulation to calm the body’s inflammatory response, a process scientists call the “neuroimmune reflex.”

This tiny implant, called the SetPoint System, developed by SetPoint Medical, is placed under the skin in the neck to deliver a low-voltage signal to the vagus nerve for just 60 seconds a day. It’s designed to activate a natural reflex that helps the nervous system detect and reduce inflammation.

In a major clinical trial, more than half of participants saw significant symptom improvement within 24 weeks.

After a year, three-quarters of patients were able to stop taking biologic or targeted synthetic drugs altogether.

The procedure was well-tolerated, with a very low rate of serious side effects (1.7%), and no major infections, cancers, or cardiac events linked to the therapy. SetPoint plans to roll out the therapy in select U.S. cities later this year, with nationwide expansion in 2026. The company is also exploring the same technology for treating multiple sclerosis and Crohn’s disease, potentially opening a new frontier in autoimmune treatment.

Citations

SetPoint Medical. (2024, November 18). SetPoint Medical announces late‑breaking data from RESET‑RA study at ACR Convergence 2024 [Press release]. SetPoint Medical.

SetPoint Medical. (2024, October 2). FDA’s IDE approval for U.S. pilot study of neuroimmune modulation platform in adults with relapsing‑remitting multiple sclerosis [Press release]. SetPoint Medical.

SetPoint Medical Corporation. (2025, January 10). Vagus nerve stimulation for moderate to severe rheumatoid arthritis (Clinical trial registration NCT04539964). ClinicalTrials.gov.