Home / Health / FDA Approves New Stroke Gait Therapy Device
FDA Approves New Stroke Gait Therapy Device
30 Jun
Summary
- FDA cleared Bioness's PoNS system for stroke rehabilitation.
- Device uses tongue stimulation to improve walking function.
- Studies showed significant walking improvements with PoNS.
Bioness Medical has received FDA clearance for its innovative PoNS system, designed to help stroke survivors improve their walking ability. This portable neuromodulation device delivers gentle stimulation through a mouthpiece placed on the tongue, activating cranial nerves to enhance brainstem connections.
The system works in conjunction with physical rehabilitation, aiming to restore corticospinal pathways and improve gait deficits. Its clearance was supported by Bioness's three-study Stroke Registrational Program (SRP), which evaluated the PoNS system's safety and efficacy over a 12-week period.
Results from the 159-patient SRP indicated statistically significant improvements on the Functional Gait Assessment (FGA) scale. Patients using PoNS plus physical therapy showed a greater mean improvement in FGA scores compared to those receiving physical therapy alone. The treatment also resulted in a notably higher response rate to therapy.
