The U.S. Food and Drug Administration (FDA) has approved an implantable device for people living with moderate-to-severe rheumatoid arthritis (RA). This device, called the SetPoint System, works by sending signals to a nerve in the body to help reduce inflammation. The device offers hope to people who haven’t gotten enough relief from standard RA treatments or can’t tolerate their side effects.

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What Was Approved?

The SetPoint System is an implantable device about the size of a vitamin tablet for adults with moderately to severely active RA who have not responded well to treatments like biologics or JAK inhibitors. The SetPoint System is the first FDA-approved device of its kind for RA.

How Does the SetPoint System Work?

Compared with medication, the SetPoint System uses gentle electrical pulses to stimulate the vagus nerve, which helps regulate the body’s immune response. The vagus nerve plays a role in controlling inflammation. For people with RA, these natural pathways may not work correctly, leading to ongoing joint pain and swelling.

During an outpatient procedure, the implant is placed on the left vagus nerve in the neck through a small incision. Once in place, it delivers 60 seconds of stimulation once per day. This signal is thought to “jump-start” the body’s natural anti-inflammatory reflexes, helping to reduce the overactive immune response seen in RA.

What Did the Clinical Trials Show?

The FDA’s approval was based on a clinical trial, which enrolled 242 people with RA who had not found enough relief from at least one biologic or JAK inhibitor. At three months, people using the SetPoint device had significantly greater improvement in their RA symptoms compared to those with a placebo (inactive) device.

After 12 months, nearly half of those treated with SetPoint achieved low disease activity (greatly reduced RA symptoms) or remission (almost no RA symptoms). Additionally, 75 percent of participants were able to stay off a biologic or targeted synthetic DMARD (advanced medication) for a full year while using the device.

What Are the Side Effects?

Around 5 percent of participants experienced hoarseness, which was the most common side effect. Just under 2 percent of participants had serious side effects. Most occurred within the first three months and included risks typical of nerve surgery, such as pain or infection at the implant site.

Why This Matters: A New Option for RA

RA is a lifelong autoimmune disease that causes joint pain and swelling, and can limit movement. Some people eventually stop responding to medications or can’t tolerate the side effects.

The SetPoint System provides a nondrug option for people whose RA isn’t controlled by existing therapies, or for those who want to avoid medications that suppress the immune system. It may also be combined with other RA treatments if needed.

SetPoint Medical plans to roll out the implant in select U.S. cities in 2025, with wider availability expected in 2026. Ask your healthcare provider or rheumatologist if you’re interested in learning more about it.

Have you wondered if your RA is worsening? Here are six signs to watch for.

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