The FDA announced today that it authorized marketing for a stimulator device that treats gait deficit in those with multiple sclerosis (MS).
Helius Medical’s portable neuromodulation stimulator (PoNS) is a neuromuscular tongue stimulator that uses a non-implantable apparatus to generate electrical pulses for stimulation of the trigeminal and facial nerves via the tongue to treat motor deficits, according to an FDA release.
PoNS is intended for prescription-only use as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and older. It is a short-term treatment for gait deficit as a result of mild to moderate symptoms from MS.
The portable, non-implantable device includes a controller and a mouthpiece connected by a cord. The mouthpiece is held lightly in place by the lips and the control unit is worn around the neck during a patient’s visit with a therapist.
Signals are sent from the controller to the mouthpiece placed on the tongue and receptors on the tongue send millions of neural impulses to the brain. The therapist, meanwhile, can connect the control unit to a computer to view usage data developed specifically for the device, offering information on how to improve the execution of the therapy.
Two clinical studies and a retrospective analysis of real-world data supported the FDA’s decision, as the first showed improved scores on the Dynamic Gait Index (DGI), the second highlighted a significant improvement in sensory organization tasks (SOT).
“MS is one of the most common neurological diseases in young adults. 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,” acting director of the FDA’s Office of Neurological & Physical Medicine Devices Dr. Christopher M. Loftus said in the release.
In April 2019, the FDA shot down Helius’ clearance bid for the portable neuromodulation device after it failed to meet its efficacy endpoint in November 2017.