FDA Approves SetPoint Neuroimmune Modulation Device for Rheumatoid Arthritis

The U.S. Food and Drug Administration has granted approval for the SetPoint System, an innovative neuroimmune modulation device designed to treat adults suffering from moderate-to-severe rheumatoid arthritis (RA). This groundbreaking device is intended for individuals who do not experience adequate relief from or cannot tolerate existing advanced RA treatments, including biological and targeted synthetic disease-modifying antirheumatic drugs (DMARDs).

The SetPoint System is an implantable device that uniquely delivers electrical stimulation to the vagus nerve once daily. This stimulation aims to activate the body's natural anti-inflammatory and immune-restorative pathways, offering a new approach to managing autoimmune inflammation. The device's approval follows positive results from the RESET-RA clinical trial, which involved 242 participants randomly assigned to receive either the SetPoint Device or a sham device.

In the study, the primary goal was to achieve a 20% improvement according to the American College of Rheumatology criteria after three months. The trial successfully met this endpoint, with participants showing sustained improvements in response rates and disease activity over 12 months. Notably, about 75% of the patients managed to stay off biologic or targeted synthetic DMARDs after a year. The implantation procedure and subsequent stimulation were well tolerated, with a low side effect rate of 1.7% for serious adverse events.

According to Dr. Mark Richardson of Harvard University, who led the trial, the approval underscores the promising potential of neuroimmune modulation as a novel therapy for autoimmune diseases. After a minimally invasive outpatient procedure, the device is programmed to operate automatically on a set schedule, with a lifespan of up to 10 years, simplifying ongoing care for RA patients.

The SetPoint device has been approved for use by SetPoint Medical, marking a significant advancement in rheumatoid arthritis treatment options.

source: https://medicalxpress.com/news/2025-08-fda-setpoint-neuroimmune-modulation-device.html