The U.S. Meals and Drug Administration has accepted the SetPoint System, a neuroimmune modulation machine for the remedy of adults dwelling with moderate-to-severe rheumatoid arthritis (RA).
The SetPoint System is indicated for sufferers who will not be adequately managed by—or can’t tolerate—present superior RA therapies, equivalent to organic and focused artificial disease-modifying antirheumatic medication (DMARDs).
The SetPoint System is an implantable, built-in neurostimulation machine that delivers electrical stimulation to the vagus nerve, as soon as day by day, and is meant to activate the physique’s innate anti-inflammatory and immune-restorative pathways.
The approval is supported by the outcomes of the RESET-RA examine, during which 242 sufferers have been randomly assigned to the SetPoint System or a sham machine.
The trial met its main efficacy finish level of American Faculty of Rheumatology 20% enchancment at three months, with enhancements seen for response charges and illness exercise metrics by means of 12 months of follow-up. Three-fourths of members have been freed from biologic or focused artificial DMARDs at 12 months. The machine placement process and stimulation remedy have been nicely tolerated, with a 1.7% price of associated severe antagonistic occasions.
“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 within the RESET-RA examine, Mark Richardson, M.D., Ph.D., from Harvard College in Boston, stated in a press release.
“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 machine was granted to SetPoint Medical.
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FDA approves SetPoint neuroimmune modulation machine for rheumatoid arthritis (2025, August 8)
retrieved 8 August 2025
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