FDA Clears Stimulation System for Foot Drop in Children

Pauline Anderson

January 25, 2013

The US Food and Drug Administration (FDA) has approved the L300 Foot Drop System (Bioness) for use in children with neurologic conditions such as cerebral palsy, multiple sclerosis, stroke, or traumatic brain injury.

In announcing it has received 510(k) clearance to market the Functional Electrical Stimulation system for use by pediatric patients and their caregivers, the company said it's the first FDA-cleared neurostimulation device of its kind for use with children. The device is already cleared for use in adults.

Foot drop is a condition that causes walking difficulty in patients with upper motor neuron conditions. For the more than 500,000 Americans suffering from the effects of cerebral palsy alone, "mobility can be a daily struggle, and results in having difficulty with many of the activities most of us consider essential to childhood," Michael Amrento, a pediatric physiatrist at Children's Specialized Hospital, a pediatric rehabilitation facility in Mountainside, New Jersey, said in a press release from the company.

"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," added Thomas G. Fogarty, president and CEO of Bioness, in the same release.

Worn on the leg, the device has 3 main parts: a small wireless sensor in the shoe, a sport brace–like leg cuff worn just below the knee, and a hand-held remote control. During the swing phase of taking a step, the device electrically stimulates muscles in the affected leg to provide dorsiflexion of the foot.

The neurostimulator can be an aid to gait rehabilitation both in an inpatient and outpatient setting. It can be used to improve mobility, maintain or increase joint range of motion, retrain muscles, prevent or slow muscle loss, and increase blood flow.

According to information on the company Web site, the L300 Foot Drop System comes in 2 sizes: regular and small (to fit calf circumferences approximately 12 inches or smaller).