FDA authorizes marketing of device to improve gait in patients with MS
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The FDA has authorized the marketing of a neuromuscular tongue stimulator to improve short-term gait deficit in adults with mild to moderate multiple sclerosis, according to a press release.
The Portable Neuromodulation Stimulator (Helius Medical Inc.) is a prescription-only device intended to be used as an adjunct to a supervised therapeutic exercise program in adults aged 22 years and older. The device uses a non-implantable apparatus to generate electrical pluses for stimulation of the trigeminal and facial nerves via the tongue to provide treatment of motor deficits.
“MS is one of the most common neurological diseases in young adults,” Christopher M. Loftus, MD, acting director of the office of neurological and physical medicine devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “Today’s authorization offers a valuable new aid in physical therapy and increases the value of additional therapies for those who live with MS on a daily basis.”
The FDA evaluated the safety and efficacy of the Portable Neuromodulation Stimulator based on two clinical studies and a retrospective analysis of real-world data. In the first study, a group of 10 adults with gait deficit due to MS using the Portable Neuromodulation Stimulator had an improvement in their Dynamic Gait Index score over a 14-week period. There was no improvement in Dynamic Gait Index score for 10 participants in a control group using a sham device. In a second study analyzing the effects of the device with cognitive rehab and physical rehab, seven participants using the Portable Neuromodulation Stimulator had an improvement in sensory organization task scores at 14 weeks compared with baseline. There was no significant result observed after 14 weeks.
No serious safety adverse events were reported in either of the clinical studies or in a retrospective analysis of real-world data.
The Portable Neuromodulation Stimulator was previously granted a breakthrough device designation by the FDA. Along with the marketing authorization, the FDA is establishing special controls for devices of this type to provide reasonable assurance of safety and efficacy.