SetPoint VNS for Rheumatoid Arthritis
SetPoint vagus nerve stimulation for rheumatoid arthritis: a guide for patients.
This guide explains SetPoint vagus nerve stimulation (VNS), a treatment for rheumatoid arthritis (RA) that uses a small implanted device. You can ask to be seen with the referral form, or your rheumatologist can refer you.
Your surgeons.
Your surgical team is Dr. Pranav Nanda and Dr. Mark Richardson. Dr. Richardson was the national surgical principal investigator for RESET-RA, the pivotal clinical trial of SetPoint. RESET-RA enrolled 242 patients at 41 sites and is the largest study of vagus nerve stimulation for RA.
What is SetPoint VNS?
SetPoint VNS sends gentle electrical signals to your vagus nerve from a small implanted device. The vagus nerve is a major nerve that runs from the brain through the neck and into the body. The FDA approved the SetPoint System in July 2025 for adults with moderately to severely active RA who have had an inadequate response, loss of response, or intolerance to one or more biologic or targeted synthetic drugs, such as anti-TNF drugs or JAK inhibitors.
How does it work?
The body has a natural anti-inflammatory system called the inflammatory reflex. In RA, this system does not keep inflammation in check. The SetPoint device stimulates the vagus nerve, which activates the reflex and reduces the production of inflammatory chemicals such as TNF, IL-1, and IL-6. Less inflammation can mean less joint pain, swelling, and stiffness.
What does the procedure involve?
The SetPoint device is a miniaturized pulse generator with built-in electrodes. It is about 1 inch (2.5 cm) long and weighs about 0.1 ounce (3 g). Older VNS devices used for epilepsy have leads tunneled to a battery pack in the chest. SetPoint has no leads. The entire device sits on the vagus nerve in your neck.
The operation is an outpatient procedure of about 60 to 90 minutes under general anesthesia.
A single incision is made in a natural skin crease on the left side of your neck.
The device is placed on the left vagus nerve within the carotid sheath.
The incision is closed with absorbable sutures and skin glue. No stitches need to be removed.
Most patients go home the same day.
How do you use the device?
Recovery takes 2 to 3 weeks before programming begins.
Your rheumatologist programs the device over 3 to 4 weekly visits.
Once programmed, the device delivers a one minute stimulation session automatically every day. You may or may not feel a mild sensation.
You recharge the battery with a wireless charger worn around your neck for a few minutes, about once a week.
The rechargeable battery is designed to last up to 10 years.
What results can you expect?
RESET-RA was a randomized, double blind, sham controlled trial of 242 patients. On average, patients had lived with RA for 12 years and had tried 2.6 biologic or targeted synthetic drugs.
At 12 weeks, 35.2% of patients receiving stimulation had an ACR20 response, meaning at least a 20% improvement in tender and swollen joints and other measures of disease activity. In the sham group the rate was 24.2% (p = 0.02).
60.7% of patients receiving stimulation had a good or moderate EULAR response by DAS28-CRP at 12 weeks, compared with 41.7% with sham stimulation.
After 12 weeks every patient received active stimulation and the study became open label. Among patients who completed follow-up, the ACR20 response rate was 50.0% at 24 weeks, 51.7% at 36 weeks, and 52.8% at 48 weeks.
Benefit builds slowly. It can take 24 weeks or longer to see the full effect, especially after several earlier drugs.
Not everyone responds. SetPoint works alongside your current RA medications.
What are the risks and side effects?
In RESET-RA, 4 of 242 patients (1.65%) had a serious adverse event related to the procedure or device through 3 months. No deaths occurred and no life threatening complications were related to the device. No serious infections, cancers, or major cardiac events were associated with the therapy through 12 months.
Surgical risks. Through 12 weeks, among 122 patients receiving stimulation:
Vocal cord weakness (paresis) occurred in about 5% (6 patients). One patient was hospitalized for voice and swallowing problems, which resolved.
Voice change (dysphonia) occurred in 3.3% (4 patients).
Trouble swallowing, cough, swelling, inflammation, numbness, or pain near the incision, and wound infection each occurred in one or two patients.
Device related side effects. About 8% of patients had a side effect from stimulation. The most common was discomfort at the device (3.3%). Cough, a choking sensation, and a change in taste each occurred in one patient. One patient had skin irritation from the charger, which resolved when fabric was placed between the charger and the skin.
Longer term. After 12 weeks, 5% of patients had a mild or moderate side effect related to stimulation, which was managed by adjusting the strength or timing of stimulation. Two patients stopped treatment because of side effects. By the time of FDA review, the device had been removed in 14 of 242 patients (5.8%). One patient had an injury to the throat during device removal that was repaired during the operation.
Who is a candidate for SetPoint VNS?
This therapy may be an option if you:
Have moderate to severe rheumatoid arthritis
Have not responded adequately to at least one biologic or targeted synthetic medication (such as anti-TNF drugs or JAK inhibitors)
Are currently on a stable conventional DMARD (such as methotrexate)
Are looking for an alternative to adding more medications
Are between 22 and 75 years of age
Do not have other implanted electrical devices (such as a pacemaker or defibrillator)
SetPoint should not be used if you have had a vagotomy or a splenectomy, if you cannot safely have general anesthesia, if spine disease in your neck makes placing a breathing tube unsafe, or if your neck is too large to wear the charger.
What should you discuss with your doctor?
Your complete treatment history and current medications
Whether you are a good candidate for this therapy
The risks and benefits specific to your situation
What to expect during recovery from the implant procedure
How this therapy fits into your overall RA treatment plan
Insurance coverage and costs
Alternative treatment options
Living with the device.
You can continue most normal activities after recovery.
The device is small and not visible under clothing.
Tell every healthcare provider, including your dentist, that you have an implanted neurostimulation device.
Tell airport security about your implanted device.
You can have an MRI at least two weeks after the implant, under specific conditions. Tell the MRI staff about your device and talk with your care team before scheduling any scan. Never bring the charger into an MRI room.
Charge the device weekly with the wireless charger.
Reminders.
SetPoint VNS does not cure rheumatoid arthritis. It helps control inflammation.
You will likely need to continue your current RA medications.
Keep your follow-up visits with both your surgeon and your rheumatologist.
Contact your care team about new symptoms.
Sources: SetPoint System Instructions for Use (RESET-RA data on file with the FDA); FDA premarket approval letter P240039, July 30, 2025.