A novel stimulant device to treat gait deficiencies in patients with multiple sclerosis (MS) with moderate to severe symptoms was won by the FDA on Friday.
The device, called the Portable Neuromodulation Stimulator (PoNS), generates electrical pulses on the tongue to stimulate trigeminal and facial nerves to address motor deficits. To be available with a prescription, it will only be used as part of a supervised therapeutic exercise program in MS patients 22 and older, the group said. The FDA authorized the device through its “de novo” pre-sale review route for new devices that are moderately low risk for adverse effects.
“MS is one of the most common brain diseases in young adults. Today’s authorization offers valuable new aids in physical therapy and increases the value of additional treatments for those living with MS each year. day, “Christopher Loftus, MD, executive director of the Office of Neurological and Physical Medicine Devices in the FDA ‘s Center for Radical Equipment and Health, said in a statement.
Most people with MS experience the first symptoms between the ages of 20 and 40 and the disease occurs more often in women than in men. MS can cause a number of symptoms, including problems with walking and balance.
The PoNS device delivers central neuromuscular electrical stimulation to the dorsal surface of the patient’s tongue. A control unit, worn around the neck, sends signals to the mouth that the patient gently holds in place with their lips and teeth. A physician can look at later usage data to “identify potential areas of missed or shortened sessions,” the FDA noted.
Two clinical studies formed the basis of the group’s favorable study. One included 20 MS patients with leg defects (10 who used PoNS; 10 who used a sham device), the PoNS group showed a “statistically significant and clinically significant” improvement in the Dynamic Gait Index scores (DGI) at 14 weeks unseen in controls, the FDA said.
The other study, in 14 patients, showed improvements from baseline in awareness organization activity scores (but not in DGI scores) at 14 weeks. No adverse safety events were reported in the clinical trials or retrospective analysis of actual data.
The PoNS tool should not be used by patients with traumatic brain injuries, neurodegenerative diseases, oral health problems, chronic infectious diseases, uncontrolled hip or diabetes, pacemakers, or a history of seizures, reported. the FDA warned. “Because the PoNS device delivers electrical stimulation directly to the surface of the tongue, precautions for its use are similar to those for transcutaneous zero electrical stimulation,” the group said. Electrical stimulation should not be used if malignant tumors are active or suspicious, near recent bleeding or open wounds, or in areas where there is no normal sensation.The PoNS device has not been tested and should not be used by people under the age of 22, who pregnant, or sensitive to nickel, gold or copper.
This was Helius Medical’s second device manufacturer to gain FDA authorization; the agency rejected the PoNS device in 2019 when the company applied for a 510 (k) route license that was less stringent, although it was adopted in Canada. It was heavily featured in the media after television host Montel Williams promoted the device in 2016, which he would use to handle his MS symptoms.