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 patient's course of therapy and allow home users better control over their knee and foot, making it easier to walk. Bioness continues to be committed to bringing innovative solutions to patients and in setting the standard of care with our advanced technology. The NESS L300 Plus represents yet another product in our pursuit of this mission."
Bioness will display the NESS L300 Plus at the upcoming Annual Conference & Exposition of the American Physical Therapy Association (APTA) June 9th – 11th at National Harbor, Maryland in Booth #419. The Company anticipates the device will become commercially available to neurorehabilitation hospitals and centers around the country and to consumers for home use within the coming weeks.
About Bioness Inc.
Bioness provides neuromodulation technologies that help improve lives and restore function for those living with neurological deficits and peripheral pain. The Company develops, manufactures and markets innovative neuromodulation products that help individuals with central nervous system disorders such as stroke, multiple sclerosis, spinal cord injury and traumatic brain injury regain movement in affected limbs. The NESS L300® Foot Drop System and NESS H200® Hand Rehabilitation System, and NESS L300® Plus System are cleared for use by the Food and Drug Administration and are designed to help patients achieve new levels of physical independence and productivity. Individual results vary. Consult with a qualified physician to find out if these products are right for you. Additional information about Bioness can be found at www.bioness.com.
NESS®, NESS L300®, NESS L300® Plus, Bioness® are trademarks of Bioness Inc. | www.bioness.com | Rx Only
Wendy Ryan/Genevieve Gadenne
SOURCE Bioness Inc.