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."