Northwell Health conducted a pioneering clinical trial to treat rheumatoid arthritis through a chip implanted on the vagus nerve. The first technology of its kind yielded impressive results, and now can be prescribed to patients under recent FDA approval.
The SetPoint System by SetPoint Medical“This is a very new thing,” said Northwell Health Dr. Kevin Tracey, president and CEO of The Feinstein Institutes for Medical Research, said about the SetPoint System. “Doctors treating rheumatoid arthritis think in terms of pills and injections as therapies, and physical therapies, of course. Now doctors and patients will be able to consider whether a computer chip may be the right therapy.”
The SetPoint System was approved by the U.S. Food and Drug Administration on July 31, giving the green light for doctors to begin offering it for their patients with rheumatoid arthritis.
“The approval of the SetPoint System, the first-in-class neuroimmune modulation platform, represents a transformative milestone in the management of autoimmune diseases,” said Murthy V. Simhambhatla, CEO of SetPoint Medical, in a press release. “We are committed to improving the health of people living with RA, and look forward to working with providers and payers to make our innovative therapy accessible to their patients.”
The SetPoint System is scheduled to come to a selection of United States cities this year before being expanded across the country early next year.
The new technology caters to patients with moderate to severe rheumatoid arthritis whose disease has not responded well to already available treatments.
Rheumatoid arthritis is an incurable autoimmune disease that causes inflammation and pain in the joints. It can often be debilitating.
The SetPoint System is an implanted device that stimulates the vagus nerve once a day. The stimulation activates the body’s anti-inflammatory and immune-restorative pathways.
Northwell Health was home to a clinical trial for the SetPoint System, which yielded positive results from patients who participated. The technology falls under the health system’s newest Center for Bioelectronic Medicine, which opened earlier this year.
Dawn Steiner, a 58-year-old speech and language pathologist from Massapequa, was one clinical trial participant whose life was bettered by the newly approved technology. After 15 years of battling the disease, the SetPoint System offered her a new chance.
“I was barely living,” Steiner previously told the Long Island Press. “It was hard for me to go out and do stuff. I just never felt good.”
About two years ago Steiner was on her eighth failing medication and was looking to see what her next step would be. That’s when she learned of the SetPoint Medical’s RESET-RA clinical trial.
“Although it was a little scary to think about a surgical procedure and all of that, it didn’t seem any less scary to me than all the meds that I had taken,” Steiner said.
Within a week, Steiner said her quality of life was already beginning to improve. Now almost two years later, Steiner is feeling the best she has in 20 years.
Since undergoing the trial, Steiner said her pain is at its lowest since her symptoms transpired. While she used to spend most of her free time in bed or on the couch due to debilitating pain, now she can go on walks and take weekend trips.
Steiner previously spoke on the importance of clinical trials, both for herself and for advancing the field of medicine. She said she was proud to be able to participate in it and considered it an overall positive experience.
“They need people like us to do things like this and give it a try,” Steiner said.
