FDA Approves Vagal Nerve Stimulator for RA Save

SetPoint Medical announced that the FDA has approved the company’s SetPoint System, a first-in-class neuroimmune modulation innovation for treatment of moderate-to-severe rheumatoid arthritis (RA) for those who are not adequately managed by—or cannot tolerate—existing advanced RA therapies, such as biological and targeted synthetic disease-modifying anti-rheumatic drugs (DMARDs).

The SetPoint System is an implantable, integrated neurostimulation device designed to deliver electrical stimulation to the vagus nerve, once daily, to activate the body’s innate anti-inflammatory and immune-restorative pathways. This groundbreaking therapy has the potential to transform the care for RA sufferers by offering a treatment option without immune-compromising risks.

FDA approval is supported by the results of the 242-patient randomized, double-blind, sham-controlled, RESET-RA study, that demonstrated the SetPoint System’s safety and efficacy in patients with moderately to severely active RA who had an incomplete response or intolerance to one or more biologic or targeted synthetic DMARDS.

The device placement procedure and stimulation therapy were well-tolerated, with a low rate of related serious adverse events (1.7%), and no observations of malignancies, major cardiac events, or serious infections related to the SetPoint Therapy.

The company is also planning to evaluate its platform for treatment of additional autoimmune indications, including multiple sclerosis and Crohn’s disease.