VALENCIA, Calif., May 10, 2011 /PRNewswire/ — Bioness Inc.
today announced that it has received 510(k) clearance from the U.S.
Food and Drug Administration (FDA) for its NESS L300® Plus
System. The device combines the Company’s NESS L300® Foot Drop
System with a thigh stimulation cuff, to provide knee flexion and
extension in addition to ankle dorsiflexion during gait. The NESS
L300 Plus is intended for persons with upper motor neuron injury or
disease resulting from stroke, multiple sclerosis, traumatic brain
injury and spinal cord injury. The device also may facilitate
muscle re-education, prevent/retard muscle atrophy, maintain or
increase range of motion and increase local blood flow.
People with upper motor neuron injuries or diseases often
experience gait movement disorders such as foot
drop, which is a result of partial leg paralysis. Gait movement
disorders not only result in difficulty walking, but may also
lead to fatigue, falls or abnormal walking patterns.
The NESS L300 Plus builds on the proven success of Bioness’ NESS
L300 Foot Drop System and is designed to additionally stimulate the
muscles of the thigh. The addition of the thigh stimulation cuff,
synchronized with a wireless heel sensor to detect when the foot is
on or off the ground, controls the knee, making it easier to walk.
Historically, patients have relied on rigid plastic braces which
restrict thigh and ankle movements and can lead to additional
problems, including increased falls.
“An estimated 12.5 million Americans live with the effects of
central nervous system injuries and disorders, and many of these
individuals have gait disorders that make it difficult if not
impossible for them to walk with freedom,” said Thomas G. Fogarty,
president & CEO of Bioness. “The NESS L300 Plus will provide
physical therapists an additional modality to optimize the pa