American neuromodulation device developer Bioness has obtained US Food and Drug Administration (FDA) approval for its L300 neurostimulation system indicated for the treatment of children suffering from foot drop.
The 510(k) clearance, claimed by the company to be first approval given by FDA to such a device for pediatric patients, now allows Bioness to market the foot drop system within the US.
According to the company, the neuromuscular stimulation device will help in treating children suffering from cerebral palsy, stroke or traumatic brain injury.
Children’s Specialized Hospital paediatric physiatrist Dr Michael Armento said; "More than 500,000 Americans suffer from the effects of cerebral palsy (CP), in addition to the large number of children affected by foot drop as a result of traumatic brain injury, stroke and other conditions."
Foot drop is an upper motor neuron ailment that creates walking difficulty in adults and children.
The L300’s neuromodulation technology is designed to help regain the confidence to walk with good speed and less fatigue.
L300, which is worn on the legs, has three important components: a small wireless sensor in the shoe, a sport brace-like leg cuff worn just below the knee and a hand-held remote control.
The device passes low-level electrical stimulation to the nerves in the lower leg whenever patient initiates a step.
The stimulated lower leg nerves, which control the muscles responsible for lifting the foot, will help bring mobility in the leg at an appropriate time, said Bioness.
Bioness president and CEO Thomas Fogarty said the device offers a therapeutic treatment option to children currently reliant on an orthosis or other compensatory aids for foot drop.
"The L300 has helped thousands of adults regain mobility and now this same technology has the potential to provide pediatric patients with improved quality of life and a level of activity more closely associated with that of a child," Fogarty said.