People with spinal cord injuries will soon have a new treatment option to improve neurological function and sensation. December 19 FORWARD Medical announced that it has received FDA clearance to market its ARC-EX transcutaneous stimulation device, making it the first transcutaneous stimulation system available for clinical use in the United States.
With a small control box and two electrodes that stick to the skin, transcutaneous stimulation devices like the ARC-EX look like functional electrical stimulation devices that people use to activate weak or paralyzed muscles. But unlike FES units, transcutaneous stimulation devices send current directly to the spinal cord to excite weak or inactive communication pathways. Research has shown that transcutaneous stimulation can improve function in people with chronic SCI and those with more complete injuries.
Now the ARC-EX device, and likely others soon, will begin arriving at SCI clinics and rehabilitation centers. ONWARD says it anticipates approval for home use in 2025.
“For the first time, there is an approved therapy that has been shown to improve hand strength and sensation after chronic spinal cord injury,” said Dave Marver, CEO of ONWARD Medical. “No longer will people be sent home and told that nothing can be done to help them regain these abilities after their injury. “We hope this will be the first of many therapies we will introduce to help people regain independence from paralysis and other movement disabilities.”
The FDA approval for the ARC-EX device was based in part on research conducted by Dr. Chet Moritz of the University of Washington to help improve hand function in people with SCI at the cervical level. Kate Willette described the results of the research in a 2018 New Mobility article:
“Finger dexterity also improved. Some might steal a debit card and stick it in an ATM, use a cell phone, or turn a key in a lock. One of them was able to uncover a bottle of water. Their average maximum grip strength had more than tripled by the end of the study, but they also, as in the epistim trials, enjoyed improvements in other quality of life measures. The feeling was better. Trunk control was more reliable. “They even made progress in bowel and bladder control.”
The research was exciting when it came to light: it is certainly not a cure, but an opportunity for real functional return. Now that same technology is on its way to widespread use.
“This approval represents a watershed moment for the SCI community,” says Maggie Goldberg, president and CEO of the Christopher & Dana Reeve Foundation. “For those living with SCI and paralysis, the wait for even a single therapy to improve their health and quality of life has been long and arduous. “We now believe this milestone signals the opening of the floodgates for future advancements.”
Subscribe to our newsletter to stay up to date on the latest news, products and professional advice for wheelchair users.
Support new mobilityWait! Before exploring other parts of the Internet, consider supporting New Mobility. For more than three decades, New Mobility has published innovative content for active wheelchair users. We share practical advice from wheelchair users across the country, review life-changing technologies, and demand equity in healthcare, travel, and all facets of life. But none of this is cheap, easy or profitable. Your support helps us provide wheelchair users with the resources to build a fulfilling life. |
