First-Of-Its-Kind Vagus Nerve Implant Gets FDA Approval As A Therapy For Rheumatoid Arthritis

A first-of-its-kind implant has just been granted approval from the US Food and Drug Administration (FDA) for the treatment of rheumatoid arthritis. Developed by SetPoint Medical, the neuroimmune modulation device works by delivering electrical stimulation to the vagus nerve once a day to initiate the body’s innate anti-inflammatory pathways. It essentially prods the body to use the tools it already has to get inflammation under control, marking a novel approach to managing autoimmune disease.

Dr Kevin J Tracey, co-founder of SetPoint Medical and author of The Great Nerve, is the first to admit that when it comes to the vagus nerve, there’s a lot of misinformation floating around. Underneath the people trying to sell you things, however, is an intriguing new field of medicine that aims to hijack this superhighway, but what does the vagus nerve actually do?

Signals traveling in the vagus nerve are operating at the level of reflexes.

Dr Kevin J Tracey

“It carries the signals back and forth between your body and your brain that maintain a balanced function of all your organs, so you don't have to think about it,” Tracey told IFLScience in the August issue of CURIOUS. “Signals traveling in the vagus nerve are operating at the level of reflexes. I call them healing reflexes, or healthy reflexes, and what they do is they are activated by changes in the function of your organs, whether it's your heart, or your kidneys, or your intestines.”

It’s curious, really, that we all know it as “the vagus nerve” because you actually have two, and each one is made up of 100,000 fibers. In the same way that you have two thumbs, or two kidneys, each one sits on either side of your body, and across the total 200,000 nerves, they carry the crucial information that keeps you healthy. Impressive, and vital to our survival.

It's so important, actually, that if you cut it on both sides, in the neck, it's fatal. You die.

Dr Kevin J Tracey

“It's so important, actually, that if you cut it on both sides, in the neck, it's fatal. You die,” said Tracey. “It's the only nerve in the body that, if you cut it on both sides, you die. That's why Galen, sort of the world's first scientist, called the vagus nerve ‘the great nerve’, and that name stood for centuries. I think it's a better name, actually.”

The SetPoint System is an implantable neurostimulation device that aims to hack into the great nerve by stimulating it once daily. This then activates a series of pathways that are an innate part of our physiology as a means to control certain illnesses, and now it’s received FDA approval as a therapy for rheumatoid arthritis.

This debilitating chronic autoimmune disease affects over 1.5 million Americans. Characterized by the immune system attacking healthy tissue, it can cause joint pain, bone erosion, and significantly reduce mobility, and there is currently no cure.

The existing treatment options include biological and targeted synthetic disease-modifying anti-rheumatic drugs, which some patients find hard to tolerate, and around 50 percent of patients discontinue their therapies within two years. SetPoint’s goal is to provide an alternative that can effectively manage autoimmune conditions without suppressing the immune system.

Its FDA approval follows a randomized, double-blind, sham-controlled study that followed 242 patients. It showed that the therapy was well-tolerated with a low level of serious adverse events related to it (1.7 percent). It also provides a long-term solution for patients living with this chronic disease.

“The approval of the SetPoint System highlights the potential of neuroimmune modulation as a novel approach for autoimmune disease, by harnessing the body's neural pathways to combat inflammation,” said the study's principal investigator, Dr Mark Richardson, Director of Functional Neurosurgery at Massachusetts General Hospital and Professor of Neurosciences at Harvard Medical School, in a statement. “After implantation during a minimally invasive outpatient procedure, the SetPoint device is programmed to automatically administer therapy on a predetermined schedule for up to 10 years, simplifying care for people living with RA.”