US EditionVagus Nerve Device OK'd for Rheumatoid Arthritis
UNITED STATES, JUL 31 – The Setpoint System reduces inflammation by stimulating the vagus nerve, with 35.2% of treated patients achieving significant symptom improvement in clinical trials.
- Approving a novel therapy, the FDA cleared the SetPoint System, the first vagus nerve stimulation device for rheumatoid arthritis in patients unresponsive to biologic or targeted synthetic DMARDs.
- Nearly 75% of rheumatoid arthritis patients express dissatisfaction with current therapies, which involve strong anti-inflammatory medications that increase vulnerabilities to infections and cancer.
- In clinical trials, 242 participants with RA showed about 35% experienced at least a 20% symptom reduction, with less than 2% facing serious adverse events.
- SetPoint plans to begin commercialization in certain US cities this year, with a larger expansion across the US planned in early 2026.
- This approval marks the first time a vagus nerve stimulation device has been authorized for autoimmune disorders and may lead to treatments for inflammation-related conditions like heart failure, diabetes, and neurodegenerative disorders.
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13 Articles
The Food and Drug Administration (FDA) approved on Wednesday a medical device that offers new hope to patients disabled by rheumatoid arthritis, a chronic condition that affects 1.5 million Americans and is often resistant to treatment. The condition is usually controlled by medications. The device represents a radical deviation from standard care, taking advantage of the power of the brain and nervous system to placate uncontrolled inflammation…
Vagus Nerve Device OK'd for Rheumatoid Arthritis
(MedPage Today) -- 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...
FDA approves vagus nerve stimulator for rheumatoid arthritis
The FDA has approved the SetPoint System, a vagus nerve stimulator from SetPoint Medical, for the treatment of rheumatoid arthritis.The device is an implantable, integrated neurostimulator about the size of a vitamin tablet that stimulates the vagus nerve for 60 seconds once daily with the goal of activating natural anti-inflammatory capabilities within the body. The device has also demonstrated
SetPoint is an innovative implant that stimulates the vagus nerve to block inflammation and paves the way for a new era in bioelectronic medicine
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