May 23, 2024

Surgery-preventing spinal stimulation poised for FDA approval

Editor's Note

A recent trial marks the last hurdle for researchers to request regulatory approval for a noninvasive alternative to spinal surgery, according to a May 20 report in MIT Technology Review.

Onward Medical’s ACRex device delivers electrical stimulation to the spinal cord via two wired electrodes placed just below the neck. According to the report, a 60-person clinical trial of the device (published the same day in Nature Medicine) is among the most comprehensive studies to date testing whether spinal stimulation can help paralyzed patients regain upper body function.

After two months of therapy and two months of therapy combined with stimulation, 90% of the trial’s 60 participants experienced improvement in strength or function of their hands or arms when the stimulator was turned off. The majority—72%—experienced improvement in both strength and function, and 87% reported improved quality of life. However, one expert quoted in the article points out that the therapy seems to work bets in people who have some ability to move below the site of their injury.

According to the report, the researchers behind the device hope it might be approved in the US by the end of this year.


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