Valencia, Calif.-based neurostimulation devices maker Bioness Inc. won the FDA’s OK for its L300 Foot Drop system, the 1st FDA-cleared device of its kind for treating children suffering from foot drop as a result of cerebral palsy or other brain injuries.
The L300 neurostimulation device, which is available for sale immediately, "sends low-level electrical stimulation to the nerves in the lower leg which control the muscles responsible for lifting the foot," according to a prepared release.
Foot drop is often the result of upper motor neuron injury or disease resulting from stroke, multiple sclerosis, traumatic brain injury, spinal cord injury and cerebral palsy, and leaves patients with difficulty walking.
The L300 system is comprised of a wireless sensor worn in the shoe, a leg cuff worn just below the knee and a hand-held remote control. The 3 components coordinate to send signals to left the leg when patients walk, mainly targeting use by patients but also appropriate for rehabilitation settings.
"Children who have traditionally relied on an orthosis or other compensatory aids now have a therapeutic treatment option that can help restore mobility and freedom in a non-invasive way. "Bioness president & CEO Thomas Fogarty said in a prepared release. "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."