FOR IMMEDIATE RELEASE

A New Hope for Rheumatoid Arthritis: FDA-Approved Nerve Implant Offers Relief, but Access Remains a Battle

A medical breakthrough born from tragedy and a lab accident is changing lives—while highlighting the frustrating gap between FDA approval and insurance coverage.

The Breakthrough

For the first time, an implanted device that stimulates the vagus nerve has been approved by the FDA to treat rheumatoid arthritis (RA). The SetPoint System, developed by neurosurgeon Kevin Tracey, received FDA approval in July 2025 following a rigorous 242-patient, randomized, double-blind trial that proved both its safety and efficacy.

The device is a small implant placed directly on the vagus nerve in the neck. It requires just one minute of electrical stimulation per day and a brief weekly wireless charging session of about five minutes.

"I feel like a brand-new person. I have not felt this good in 20 years."
— Jessica Hancock, patient who received the implant in October 2025

How It Works

The SetPoint System activates the body's "inflammatory reflex"—a natural biological pathway that reduces immune activity and the production of inflammatory proteins. In essence, it tells the immune system to stop overreacting.

This discovery traces back to a 1990s lab accident in Tracey's lab, where an anti-inflammatory drug injected into a mouse's brain unexpectedly reduced inflammation throughout the entire body. That finding led to the identification of the vagus nerve's critical role in controlling systemic inflammation.

Tracey's research was itself driven by a personal tragedy: the 1985 death of an infant from inflammatory complications after severe burns.

"My personal philosophy is to ask questions that can be studied scientifically in order to forge a path to inventing new therapies."
— Kevin Tracey, president and CEO of Feinstein Institutes

The Scale of the Problem

An estimated 1.5 million adults in the United States and 18 million people worldwide suffer from rheumatoid arthritis, a chronic autoimmune disease that causes painful joint inflammation and can lead to permanent damage.

The Insurance Hurdle

Despite the FDA's stamp of approval, many patients who could benefit from the SetPoint System are being denied coverage by their insurers.

The device was only available to 250 patients during its clinical trial. More than 30,000 people expressed interest in receiving it.

"You have 30,000 people who wanted this thing when there were 250 spots... and you have the insurance company saying, 'No, we're not paying because it's too new.'"
— Kevin Tracey

This creates a painful paradox: a safe, effective, FDA-approved treatment exists, but many of the patients desperate for it cannot access it due to insurance policies that label it as "experimental" or "too new."

Key Facts at a Glance

For patients like Jessica Hancock, the device has been life-changing. For the thousands still waiting, the battle is now with insurance—not just the disease.