May 2021

FDA GRANTS US MARKETING AUTHORIZATION FOR DEVICE TO IMPROVE GAIT IN MS PATIENTS

The U.S. Food and Drug Administration granted marketing authorization to Helius Medical for a new device indicated for use as a short-term treatment of gait deficit due to mild to moderate symptoms from multiple sclerosis (MS). The device, called Portable Neuromodulation Stimulator (PoNS), is a neuromuscular tongue stimulator that consists of a portable, non-implantable apparatus to generate electrical pulses for stimulation of the trigeminal and facial nerves via the tongue to provide treatment of motor deficits. It is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over, by prescription only.

The PoNS device consists of a controller and a mouthpiece that are connected to each other by a cord. The mouthpiece is held lightly in place by the lips and teeth and the control unit is worn around the neck during a patient’s visit with a therapist. The controller sends signals to the mouthpiece placed on the tongue; receptors on the tongue send millions of neural impulses to the brain through natural pathways. Additionally, the therapist can connect the control unit to a computer and view usage data via software developed specifically for the PoNS device. The usage data gives the therapist information on how to improve a patient’s execution of therapy by identifying potential areas of missed or shortened sessions.

The FDA assessed the safety and effectiveness of the PoNS device through two clinical studies and a retrospective analysis of real-world data (RWD). No serious safety adverse events were reported in the clinical studies or retrospective analysis of RWD.

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