SetPoint Medical's vagus nerve stimulator implant won FDA approval for treating rheumatoid arthritis (RA), the company announced
Thursday. It's the first electrical therapy to win the agency's OK for the condition.
Its approved indication is moderate-to-severe RA that cannot be controlled with targeted medical therapies such as biologics or Janus kinase inhibitors, either because they were ineffective or patients couldn't tolerate them.
In a pivotal, sham-controlled clinical trial reported last year, 51.5% of patients receiving active stimulation achieved ACR20 responses (20% improvement in symptoms by American College of Rheumatology criteria) after 24 weeks. About the same proportion of control patients also achieved ACR20 responses when their devices were turned on for 12 weeks.
Vagus nerve stimulation has been postulated to relieve RA symptoms through a "neuroimmune reflex," in which the nervous system senses inflammatory reactions and dials them back.
To be sold as the SetPoint System, the device is surgically inserted into the left side of the neck, where it delivers low-voltage electrical stimulation to the vagus nerve for 60 seconds once daily. It looks like a large capsule about 3 cm in length. Patients can recharge it themselves wirelessly while implanted.
In announcing the approval, SetPoint said that after a year of follow-up, 75% of patients treated with the device "were free of biologic or targeted synthetic DMARDs [disease-modifying anti-rheumatic drugs]."
"The device placement procedure and stimulation therapy were well-tolerated," the company added, "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."
A phased commercial roll-out is planned. SetPoint said it would be available later this year "in targeted U.S. cities, followed by expansion across the country starting in early 2026."
SetPoint also said it plans to investigate the technology for treating multiple sclerosis and Crohn's disease.
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