Bioness Inc. has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its L300 Foot Drop System to pediatric patients and their caregivers.
“More than 500,000 Americans suffer from the effects of cerebral palsy, in addition to the
large number of children affected by foot drop as a result of traumatic brain injury, stroke and
other conditions,” Michael Armento, MD, Children’s Specialized Hospital, Mountainside, N.J., stated in a press release. “Having another potential intervention to offer children and families impacted by foot drop opens up the opportunity for us to not only promote physical development, but improve the independence of these children.”
The L300 includes small wireless sensor in the shoe, a sport brace-like leg cuff and a hand-held remote control. When an individual initiates a step, the L300 sends low-level electrical stimulation to the nerves in the lower leg, which control the muscles responsible for lifting the foot.
“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,” Thomas G. Fogarty, president and chief executive officer of Bioness, stated in the release.