You know the vagus nerve, this famous “miracle” nerve connecting the intestine and the brain, including electrical stimulation has been the subject of much discussion for several years now? Refractory epilepsy, depression, Crohn's disease, migraines, chronic pain, diabetes, osteoarthritis, multiple sclerosis, recovery from a stroke…the list of conditions potentially affected by its stimulation continues to grow.
Why such a heterogeneous list? Because after several decades of research, and even if the precise mechanisms of the effects of the stimulation of this 10e The cranial nerve remains poorly understood, many studies demonstrate that its activation reduces systemic inflammation but also pain, highlighting a complex relationship between the nervous and immune systems.
Example here with rheumatoid arthritis, a chronic autoimmune inflammatory disease causing pain, swelling and, eventually, joint destruction characterized by persistent synovial inflammation. The latter leads to bone erosion and joint deformity.
Since first tests communicated in 2019 during an international congress, Many teams have been interested in the potential of vagal stimulation, particularly for this disease which progresses in capricious flare-ups. Although its treatment is currently purely medical, the disease, resistant to immunosuppressive drugs, often remains difficult to treat. These are the researchers from the firm Set Point Médical which were the fastest, with the development of a subcutaneous implant.
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A chip about 2.5 cm long
As the magazine announced this summer New Scientist, This is an original alternative to medical treatment with a radically different approach. And it is the first time that a non-drug treatment has been proposed for this condition. Indeed, the Food and Drug Administration (FDA) has just given the green light to this new, fully implantable device, which uses electrical signals to control inflammation.
With this new approach, everything relies on a chip about 2.5 cm long surgically implanted under the skin of the patient's neck to send regular electrical stimulations to the famous nerve for one minute per day. Led by Set Point Medical, ua phase 2 study, RESET-RA, presented last year at the American Congress of Rheumatology had proven encouraging in around 250 patients followed for a year after implant placement. More than half of them had seen an improvement in their health, and three-quarters of them were able to stop their basic treatment.
Since then, the company has submitted its application to the FDA and the regulatory steps followed until this green light. According to a spokesperson quoted by the New York Times, The device would cost less than a year of some current treatments and could last up to ten years. However, the long-term efficacy and safety of this device still need to be demonstrated, as these are not yet known and will need to be validated by a duly published clinical trial. The FDA, for its part, required post-marketing monitoring of patients and adverse events as part of its summer approval.