FDA Approves First Vagus Nerve Stimulation Device for RA

The FDA has approved a medical device that stimulates the vagus nerve for the treatment of moderate-to-severe rheumatoid arthritis (RA) in patients who have not responded to — or cannot tolerate — biologic or targeted synthetic disease-modifying antirheumatic drugs (DMARDs). 

The device, developed by SetPoint Medical in Valencia, California, is the first treatment of its kind approved for RA. The company is also planning trials for multiple sclerosis and Crohn’s disease. 

Implanted into the neck, the Setpoint System is a multivitamin-sized device that stimulates the vagus nerve for 1 minute every day and “is designed to activate innate anti-inflammatory pathways in the vagus nerve to reduce inflammation and restore immunologic setpoint,” according to a press release from SetPoint Medical on July 31. 

The device’s approval was based on a randomized, double-blinded, and sham-controlled clinical study of 242 patients with RA. At 3 months, 35.2% of patients in the treatment group achieved 20% improvement in American College of Rheumatology response criteria (ACR20), compared with 24.2% in the sham group, according to trial results presented at the 2024 ACR annual meeting held in Washington, DC.

ACR response rates and disease activity metrics improved over 12 months of follow-up, John Tesser, MD, a principal investigator of the trial, said in a statement. At 1 year, “75% of patients in the study were free of biologic or targeted synthetic DMARDs,” he said.

Commercialization of the device will begin in certain US cities this year, with a larger expansion across the US planned in early 2026. SetPoint could not provide specifics on which cities are selected for this phased roll out due to confidentiality requirements.