New neck implant offers hope for easing rheumatoid arthritis

WASHINGTON – The Food and Drug Administration (FDA) of the United States on July 27 approved a medical device that offers new hope to patients incapacitated by rheumatoid arthritis, a chronic condition that afflicts 1.5 million Americans and is often resistant to treatment.

The condition is usually managed with medicine. The device represents a radical departure from standard care, tapping the power of the brain and nervous system to tamp down the uncontrolled inflammation that leads to the debilitating autoimmune disease.

The SetPoint System is an inch-long device that is surgically implanted into the neck, where it sits in a pod wrapped around the vagus nerve, the largest nerve in the body. The device electrically stimulates the nerve, a sort of information freeway through the body, for one minute each day.

The stimulation can turn off crippling inflammation and “reset” the immune system, research has shown. Most drugs used to treat rheumatoid arthritis suppress the immune system, leaving patients vulnerable to serious infections.

On a recent episode of the American College of Rheumatology podcast, the SetPoint implant was described as representing a “true paradigm shift” in treatment of the disease, which until now has relied almost entirely on an evolving set of pharmaceuticals, from gold salts to powerful agents called biologics.

The FDA designated the implant as a breakthrough in 2024 in order to expedite its development and approval. It represents an early test of the promise of so-called bioelectronic medicine to modulate inflammation, which plays a key role in diseases including diabetes, heart disease and cancer.

Clinical trials are already under way, testing vagus nerve stimulation to manage inflammatory bowel disease in children, lupus and other conditions. Trials for patients with multiple sclerosis and Crohn’s disease are also planned.

In a year-long randomised controlled trial of 242 patients that included a sham-treatment arm, over half the participants using the SetPoint implant alone achieved remission or saw their disease recede. Measures of joint pain and swelling fell by 60 per cent and 63 per cent, respectively.

The most common serious complication was hoarseness associated with the implantation surgery, which just under 2 per cent of participants experienced.

The device’s long-term effectiveness and safety outside a clinical trial are not yet known. The FDA required post-marketing monitoring of patients and adverse events as part of the approval. NYTIMES