FDA Approves First Implant That Zaps Rheumatoid Arthritis

By Madora Pennington

A nerve stimulation implant recently approved by the FDA reduces symptoms of rheumatoid arthritis by stimulating the vagus nerve with mild electronic pulses. It’s the first FDA-approved neuromodulation device for adults with moderate-to-severe rheumatoid arthritis (RA).

The vagus nerve stimulator (VNS), created by SetPoint Medical of Valencia, California, is the size of a coffee bean. It is implanted in the left side of the neck under anesthesia during an outpatient procedure.

The device delivers electronic pulses into the vagus nerve for just one minute each day to calm the immune system and have an anti-inflammatory effect. RA causes the immune system to attack the lining of joints, damaging cartilage and eroding bone.

“The approval of the SetPoint System, the first-in-class neuroimmune modulation platform, represents a transformative milestone in the management of autoimmune diseases,” Murthy Simhambhatla, PhD, CEO of SetPoint Medical, said in a press release. “We plan to introduce the SetPoint System in targeted U.S. cities this year, followed by expansion across the country starting in early 2026.”

In auto-immune diseases like RA, the function of the vagus nerve becomes impaired. The nerve starts in the brainstem and runs through the neck, chest and abdomen, where it branches out into many organs.

The vagus nerve helps regulate the nervous system, including heart rate, blood pressure, respiration and digestion. When the nerve malfunctions, it causes inflammation and disrupts the immune system.

In a clinical trial of 242 patients, just over half (51.5%) had at least a 20% improvement in RA symptoms after 24 weeks with the SetPoint implant. Most patients tolerated the device well, but two experienced side effects of vocal cord weakness and hoarseness.

SETPOINT MEDICAL IMAGE

The SetPoint System is intended for RA patients who have not benefited from medications designed to calm the immune system, known as Disease-Modifying Antirheumatic Drugs (DMARDS) or the much stronger biologics that target specific immune cells. Doctors can monitor the device with an iPad application and patients can recharge it themselves with a wireless charger.

Vagus nerve stimulation is not new. In 1997, the FDA approved VNS for epilepsy. The implanted device is installed in the chest like a pacemaker to reduce seizures or even stop ones in progress.  

VNS can also treat chronic pain, by helping the brain "turn down" pain signals and reduce pain indirectly through its anti-inflammatory effects.  

Other types of pain for which VNS has demonstrated effectiveness are chronic migraine, chronic primary headache, cluster headache, fibromyalgia, chronic pancreatitis, esophageal pain, irritable bowel syndrome, neuropathic pain, musculoskeletal pain, osteoarthritis, and chronic low back pain.

SetPoint is investigating whether its technology can also treat multiple sclerosis, Crohn's disease and other autoimmune conditions.

Study Finds Vagus Nerve Stimulation Delays Pain Signals

By Pat Anson, PNN Editor

Neuromodulation devices that stimulate a key nerve in the neck – the vagus nerve --- have shown potential in treating a variety of chronic pain conditions, including migraines and autoimmune diseases. A new study helps us understand how the devices work.

Researchers studying post-traumatic stress disorder (PTSD) found that vagus nerve stimulation appears to dampen and delay how the brain responds to pain signals.

"It's thought that people with certain differences in how their bodies -- their autonomic and sympathetic nervous systems -- process pain may be more susceptible to PTSD," said Imanuel Lerman, MD, a pain management specialist and associate professor at the University of California San Diego School of Medicine. “And so we wanted to know if we might be able to re-write this 'misfiring' as a means to manage pain, especially for people with PTSD."

UC SAN DIEGO HEALTH

Lerman and his colleagues at Veterans Affairs San Diego Healthcare System used functional magnetic resonance imaging (fMRI) to get a look at the brains of 30 healthy volunteers after a painful heat stimulus was applied to their legs.

Half were treated with vagus nerve stimulation (VNS) for two minutes -- via electrodes placed on the neck – before the heat stimulus. The other half received a mock stimulation.

Researchers found that VNS delayed the response to heat stimulus in several areas of the brain known to be important for sensory and emotional pain processing. These pain-related brain regions were activated ten seconds later than participants who received sham stimulation. Volunteers who received VNS also sweated less in response to the heat.

“Not everyone is the same -- some people may need more vagus nerve stimulation than others to achieve the same outcomes and the necessary frequencies might change over time -- so we'll need to personalize this approach," said Lerman, who reported his findings in the journal PLOS ONE.  "But we are hopeful and looking forward to the next steps in moving this approach toward the clinic."

The next step for researchers is to conduct a clinical study of VNS on military veterans in the San Diego area. They want to determine if at-home vagus nerve stimulation can reduce emotional pain and neural inflammation associated with PTSD. People with PTSD often have intrusive memories, negative thoughts, anxiety and chronic pain. It is usually treated with psychotherapy, anti-depressants and anti-anxiety medications.

The Food and Drug Administration has approved VNS for the treatment of pain caused by cluster headache and migraine. A handheld device – called gammaCore –  is currently available by prescription for $600 to treat those conditions. 

The Feinstein Institute for Medical Research recently reported that VNS significantly reduced pain and fatigue associated with lupus, an autoimmune disease that damages joints, skin and internal organs. In a small pilot study, lupus patients who were treated with VNS for five minutes daily had a significant decrease in pain and fatigue after just five days.

An implanted vagus nerve stimulator is also being tested for the treatment of rheumatoid arthritis.