Bioness Inc. 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 US centres.
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 centres 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.”
Bioness provides neuromodulation technologies that help improve lives and restore function for those living with neurological deficits and peripheral pain.