VALENCIA, Calif., Oct. 4, 2011 /PRNewswire/ --Bioness Inc. today announced that the company has completed the initial enrollment phase of the FASTEST study to further examine the impact of its NESS L300 wireless neurostimulation technology on individuals with foot drop as a result of stroke. The FASTEST study aims to demonstrate the superiority of the NESS L300® Foot Drop System over standard therapy with an ankle-foot orthosis (AFO), and has enrolled 176 patients at 11 U.S. centers.
The NESS L300 provides an electrical stimulus to the muscles of the lower leg in order to help lift the foot up while walking. The system was cleared by the FDA in 2006, and received CE Mark from the European Union in 2007. The NESS L300 is currently available in rehabilitation centers across the country, and for home use by individuals suffering from foot drop as the result of neurological conditions including stroke, multiple sclerosis (MS), traumatic brain injury (TBI) and spinal cord injury (SCI).
Patients enrolled in the study receive rehabilitation therapy with either the NESS L300 or an AFO, and will be followed for six months and evaluated based on gait function, stroke-specific quality of life and safety.
“We are pleased to have reached this milestone and are greatly appreciative of the commitment and support of our clinical partners in reaching this goal,” said Thomas Fogarty, President of Bioness Inc. “We look forward to seeing the outcome of this study and further quantifying the impact of this important technology for those who need it most.”
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 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, NESS L300® Plus System and NESS H200® Wireless Hand Rehabilitation 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.
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SOURCE Bioness Inc.
