Chicago Hospital Pioneers Vagus Nerve Implant for Arthritis Relief

CHICAGO, IL – February 03, 2026 – For the millions of Americans battling the debilitating effects of rheumatoid arthritis, a new frontier in treatment has arrived in Chicago. Rush University Medical Center recently performed the city's first procedures to implant the SetPoint System, a novel device that uses electrical stimulation of the vagus nerve to combat the chronic autoimmune disease.

The therapy, developed by SetPoint Medical, represents a significant shift away from traditional drug-based treatments. It offers a new lifeline for patients with moderately-to-severely active rheumatoid arthritis (RA) who have not found relief with, or cannot tolerate, existing advanced medications like biologics or targeted synthetic drugs.

The landmark procedures were performed by Dr. Webster Crowley, Professor in the Department of Neurosurgery and Radiology at Rush. “This is an important milestone for bringing a new, device-based treatment approach for RA patients in Chicago,” said Dr. Crowley. “Neuroimmune modulation represents an exciting area of innovation, and this milestone reflects Rush University’s commitment to advancing research-driven therapies for patients living with chronic conditions like RA.”

A New Frontier in Autoimmune Treatment

Unlike pharmaceuticals that often suppress the entire immune system to control inflammation, the SetPoint System leverages the body's own neural pathways. The therapy centers on a concept known as neuroimmune modulation, specifically targeting the inflammatory reflex—a natural mechanism discovered decades ago that regulates the body's immune response.

The system consists of a tiny implantable device, roughly the size of a vitamin tablet, that is surgically placed on the left vagus nerve in the neck during a short outpatient procedure. Once implanted, it is programmed to deliver a subtle, one-minute electrical stimulation each day. This targeted stimulation activates an anti-inflammatory response, reducing the production of cytokines like TNF and IL-6, which are key drivers of RA inflammation and joint damage. The approach is designed to restore the body's natural immunologic balance rather than introducing external chemical agents.

This represents a paradigm shift for a condition long managed by a cycle of escalating drug therapies. For patients who have exhausted their options, a device-based therapy that works with the body's own systems offers a fundamentally different approach to managing their chronic illness.

Addressing a Critical Unmet Need

The introduction of the SetPoint System addresses a significant gap in the current RA treatment landscape. While biologic and targeted synthetic DMARDs have been transformative for many, a substantial portion of patients do not achieve adequate disease control or lose their response over time. Research indicates that up to 50% of patients discontinue these advanced therapies within two years due to insufficient efficacy or intolerable side effects, which can include an increased risk of serious infections.

The FDA's approval of the SetPoint System was based on the rigorous, double-blind, sham-controlled RESET-RA study involving 242 patients. The results, published in the prestigious journal Nature Medicine, demonstrated both the safety and efficacy of the therapy. The trial met its primary endpoint, showing a statistically significant improvement in disease activity at three months compared to a sham (non-therapeutic) stimulation.

Crucially, these benefits were sustained over time. At the 12-month mark, patients continued to show improvements in disease activity, and an impressive 75% of participants remained free of biologic or targeted synthetic drug therapies. Furthermore, patient feedback from the trial was overwhelmingly positive, with nine out of ten participants stating they would recommend the therapy to a family member or friend for RA treatment.

“Treating the first patients in Chicago is an important step forward as we continue expanding clinical access to the SetPoint System,” said Murthy V. Simhambhatla, Ph.D., CEO of SetPoint Medical. “We are grateful to Dr. Crowley for his leadership in expanding access to neuroimmune modulation therapy for RA patients who are inadequately managed by existing advanced therapies.”

Chicago at the Forefront of Medical Innovation

The adoption of this cutting-edge technology places Rush University Medical Center, and the broader Chicago medical community, at the forefront of a new era in autoimmune care. By serving as the first center in the city to offer the SetPoint System, Rush reinforces its reputation as a leader in embracing and implementing innovative, research-driven treatments.

This expansion is not limited to a single academic center. Access to the therapy is also becoming available through select rheumatology clinics in the greater Chicago area, including Willow Rheumatology in Willowbrook and Arnold Arthritis and Rheumatology in Skokie. This growing network ensures that more patients in the region who have struggled with conventional treatments will have the opportunity to explore this new option.

The collaboration between an innovative medical technology company like SetPoint Medical and a leading academic institution like Rush highlights a powerful model for accelerating the adoption of breakthrough therapies, moving them from clinical trials into real-world clinical practice where they can directly impact patient lives.

The Science and Safety Behind the Breakthrough

The SetPoint System is the first and only FDA-approved neuroimmune modulation device for rheumatoid arthritis. While the concept of vagus nerve stimulation is not new—it has been used for decades to treat epilepsy and depression—its application for an autoimmune disease like RA is revolutionary.

The safety profile established in the RESET-RA study was a key factor in its FDA approval. The study reported a low rate of serious adverse events related to the therapy (1.7%). Importantly, there were no device-related malignancies, major adverse cardiac events, or serious infections, risks often associated with long-term immunosuppressant drug use.

As with any surgical procedure, there are risks. Potential adverse events include pain or infection after surgery, as well as hoarseness, coughing, or throat irritation, which are known complications of vagus nerve procedures. However, for many patients whose lives are severely impacted by uncontrolled RA, the potential benefits of a durable, non-pharmacological solution may present a compelling alternative.

Looking ahead, SetPoint Medical is already exploring the potential of its platform technology for other chronic autoimmune conditions. The company has received FDA approval for a pilot study to evaluate the device in patients with multiple sclerosis and is planning future investigations for conditions like Crohn's disease, suggesting that the successful application in rheumatoid arthritis may just be the beginning for this innovative therapeutic approach.