FDA approves SetPoint neuroimmune modulation device for rheumatoid arthritis

The U.S. Food and Drug Administration has approved the SetPoint System, a neuroimmune modulation device for the treatment of adults living with moderate-to-severe rheumatoid arthritis (RA).

The SetPoint System is indicated for patients who are not adequately managed by—or cannot tolerate—existing advanced RA therapies, such as biological and targeted synthetic disease-modifying antirheumatic drugs (DMARDs).

The SetPoint System is an implantable, integrated neurostimulation device that delivers electrical stimulation to the vagus nerve, once daily, and is intended to activate the body’s innate anti-inflammatory and immune-restorative pathways.

The approval is supported by the results of the RESET-RA study, in which 242 patients were randomly assigned to the SetPoint System or a sham device.

The trial met its primary efficacy end point of American College of Rheumatology 20% improvement at three months, with improvements seen for response rates and disease activity metrics through 12 months of follow-up. Three-fourths of participants were free of biologic or targeted synthetic DMARDs at 12 months. The device placement procedure and stimulation therapy were well tolerated, with a 1.7% rate of related serious adverse events.

“The approval of the SetPoint System highlights the potential of neuroimmune modulation as a novel approach for autoimmune disease, by harnessing the body’s neural pathways to combat inflammation,” the principal investigator in the RESET-RA study, Mark Richardson, M.D., Ph.D., from Harvard University in Boston, said in a statement.

“After implantation during a minimally invasive outpatient procedure, the SetPoint device is programmed to automatically administer therapy on a predetermined schedule for up to 10 years, simplifying care for people living with RA.”

Approval of the SetPoint device was granted to SetPoint Medical.

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