Newly Approved Device Is the First Non-Drug Medical Treatment for RA  

By Linda Rath | Oct. 15, 2025  

For decades, the only medical treatments for rheumatoid arthritis (RA) and other autoimmune diseases have been medications. These drugs work by turning off parts of the immune system that cause inflammation. But they don’t work well for everyone. For some people, medications help for a while, then suddenly stop working. People may quit taking RA drugs because they don’t work well enough, they can’t tolerate the side effects or they cost too much. Some people cycle through round after round of drugs to find one that works for them.   

Now, there’s another option. The Food and Drug Administration (FDA) has approved the first nondrug treatment for RA, called the SetPoint System. It’s a very small device — about the size of a jelly bean — that uses electrical pulses to stimulate the vagus nerve. Unlike medications, the device does not suppress the immune system and increase the risk of serious infections.   

What Is the Vagus Nerve?  

The vagus nerve is the longest in the body. It carries messages between your brain, heart, lungs and digestive tract and helps control many automatic body functions. It has two strands, one on each side of the neck. One branch controls muscles and nerves in the throat and larynx; the other affects the ears and spine.  

Years ago, neurosurgeon Kevin Tracy, MD, who heads the Feinstein Institutes of Medical Research at Northwell Health in New York, and his colleagues discovered that the vagus nerve sends anti-inflammatory signals to the rest of the body. Dr. Tracy reasoned that stimulating the nerve could curb inflammation and control chronic and autoimmune diseases like RA. That eventually led to developing the SetPoint System. 

Similar vagus nerve devices are used to treat epilepsy, depression, migraine headaches and stroke rehabilitation. More than 150,000 people already use an implanted or external vagus nerve stimulation (VNS) device. Researchers are also studying it for inflammatory bowel disease, multiple sclerosis, Alzheimer’s disease, Parkinson’s disease and diabetes. 

How It Works 

The SetPoint System is a tiny titanium and ceramic pod that contains a battery and a neurostimulator. It takes about an hour to an hour and a half to surgically place it directly on the vagus nerve. It sends an electrical pulse to the vagus nerve for one minute a day. It needs to be recharged for five minutes once a week and it lasts for up to 10 years.  

Through years of trials, “[SetPoint researchers] identified the specific fibers in the vagus nerve and defined the precise stimulation parameters to activate anti-inflammatory reflexes,” explains David Chernoff, MD, chief medical officer of SetPoint Medical. 

Once activated, the vagus nerve sends signals to the brain. The brain then messages the spleen, and the spleen reduces production of inflammatory proteins, especially those called tumor necrosis factor (TNF), which are major drivers of RA.  

The RESET-RA Study 

FDA approved the SetPoint System based on a randomized controlled trial of 242 adults with moderate to severe RA. All had tried at least one biologic or targeted disease-modifying anti-inflammatory drug (DMARD) and had not found one that worked for them.  

Phoenix rheumatologist and researcher John Tesser, MD, who was a principal investigator for the second phase of the study, called RESET-RA, had seven patients enrolled in the trial.  

“If you look at the trial as a whole, you see that 30% of participants got 20% better. That doesn’t look all that great, but you have to consider that two-thirds of patients had already tried two or more therapies. So you had many patients who had a long disease duration (up to 13 years) with many therapies. Patients who had only tried one TNF did better,” he explains. 

At six months, half the trial participants were 20% better. Of his own patients, he says, “I had two out of seven who didn’t do well. The rest did moderately to extremely well.”  

And the benefits seem to accumulate over time. About 80% of the patients were not prescribed more advanced therapies, he adds. That suggests SetPoint continued to work for them. “Most patients had reached over 500 days with the device and a conventional DMARD.” 

Typically, about half of patients stop taking their RA medication within three years, Dr. Tesser says, He thinks they are more likely to stick with the nerve device because it doesn’t seem to have long-term side effects and doesn’t require needles.   

Who It’s For 

The SetPoint System is approved only for people who have tried and not been helped by at least one biologic or targeted DMARD. Others who might eventually be considered for it include those who: 

• Are at high risk of serious infections, heart problems, venous thrombosis or cancer 
• Are afraid of needles 
• Prefer not to use or can’t physically tolerate drugs 
• Have limited access to medical care 

Risks and Complications 

In the RESET-RA trial, 4 patients out of 242 experienced serious effects. These included: 

• swelling at the surgery site that interfered with their breathing and swallowing 
• heart palpitations 
• temporary vocal cord paralysis  

All resolved relatively quickly, although some still have mild hoarseness.  

“What is important is that there were no infections, malignancies, MACE (major adverse cardiac events) or venous thrombosis, which we worry about with drugs,” Dr. Tesser says.  

One drawback of the study: Most participants were older white women. It isn’t known yet if it will work the same for other racial and ethnic groups. That’s why the FDA requires drug and device manufacturers to continue studying their products in the real world. These studies ensure that a device is safe and effective for most users. Their results also influence whether insurance will cover their costs and treatment guidelines. 

Costs and Insurance Coverage 

The cost of the device isn’t clear. According to Dr. Chernoff, “the one-time cost to a payer or insurance company will be less than the annual cost of an RA drug alternative, like a biologic or JAK inhibitor ($75,000 to $90,000 a year). Similar to drugs, the patient’s out-of-pocket cost will vary and depend upon their insurance plan’s copay and deductibles.”   

But insurance coverage is not certain. Some insurers cover the treatment for some conditions but not others.  

“Widespread acceptance takes a while,” Dr. Tesser says. “The first year-plus, it’s hard to get approved by the payer, and rheumatologists tend to be a conservative bunch who don’t like to adopt new therapies upon initial approval. We have to educate rheumatologists about the science to get them to accept it.” But patients are already asking about it, he adds. “We’re referring [those who are interested] to Mayo Clinic.”  

Other Vagus Nerve Techniques 

Some nonsurgical methods may also help stimulate the vagus nerve that are free or low-cost and supported by science. The following are backed by Cleveland Clinic: 

• Exercise 
• Massage 
• Singing, humming or listening to music 
• Ice baths or cold showers 
• Meditation and deep breathing. A small study found that medication and deep breathing was as effective as external vagus nerve stimulation for some people with lupus.