FDA clears Bioness smaller leg cuff for use with L300 Foot Drop System

Bioness Inc. today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market a smaller leg cuff for use with the company's L300® Foot Drop System. The L300 is a neuromodulation technology designed to treat foot drop, a condition which causes difficulty walking for those with upper motor neuron injury or disease resulting from stroke, multiple sclerosis, traumatic brain injury, spinal cord injury and cerebral palsy. The new cuff size provides access to the L300 for patients with smaller calf sizes.

“While the L300 Foot Drop System has provided life-changing benefits to many individuals suffering with debilitating neurological conditions, we have always known that there are additional populations - particularly individuals of smaller stature - who could benefit from this device”

"While the L300 Foot Drop System has provided life-changing benefits to many individuals suffering with debilitating neurological conditions, we have always known that there are additional populations - particularly individuals of smaller stature - who could benefit from this device," said Thomas G. Fogarty, president & CEO of Bioness. "With the availability of a smaller cuff size with the L300 we hope to help many more individuals regain mobility, restore confidence and get back their independence, ultimately improving their quality of life."

The L300 Foot Drop System can be used for mobility rehabilitation in inpatient or outpatient rehabilitation settings, as well as in the home, to help potentially realize a variety of clinical benefits including improved mobility, maintaining or increasing range of motion, re-educating muscles and preventing or slowing muscle loss.

Worn on the leg, the L300 has three main parts: a small transmitter in the shoe, a leg cuff wrapped just below the knee and a hand-held remote control. The three components use wireless communication to "talk" to each other. When an individual tries to walk, the L300 sends low-level electrical stimulation to activate the nerves in the lower leg which control the muscles responsible for lifting the foot, helping individuals to walk and lessening the restrictions experienced with foot drop.

The smaller-size leg cuff is now available for purchase as an upgrade to an existing L300 system, or with a new L300 program. Individuals interested in more information can contact Bioness at 800-211-9136, Option 2.