VALENCIA, Calif.--(BUSINESS WIRE)--Bioness, Inc. today announced positive results from the Company’s 42-week Functional Ambulation: Standard Treatment vs. Electrical Stimulation Therapy (FASTEST) trial of the Bioness L300® Foot Drop System. The results have been published in the July issue of PM&R. The study, titled “Response and Prediction of Improvement in Gait Speed from Functional Electrical Stimulation in Post-Stroke Drop Foot,” demonstrated that persons with drop foot following stroke had clinically meaningful and statistically significant improvement in gait speed when using the Bioness L300.
“The long-term consequences of stroke, including limitations in mobility and walking, can be particularly isolating for patients. Often stroke survivors become dependent on others to complete self care and get around in the house and, especially, the community,” said Michael W. O’Dell, M.D., chief of clinical rehabilitation services, New York-Presbyterian/Weill Cornell Medical Center, and lead author on the paper. “This study demonstrates that subjects with chronic stroke can achieve a meaningful improvement in the speed of their ambulation with functional electrical stimulation therapy. Moreover, at 42 weeks the subjects in this study walked faster with and without the device, indicating a therapeutic effect that can be sustained over time.”
Subjects using the L300 had their gait speed progressively improve over 42 weeks, with ≥50% of subjects achieving a clinically meaningful 42-week total effect and 50% achieving their maximum gait speed by 12-weeks. As a whole, the group experienced an immediate increase of walking speed of 19% which continued to improve to 33.3% and 45.2% at 30 and 42 weeks, respectively. “In addition to statistically important changes, we documented practical, clinically important changes in gait speed as a result of the treatment,” said Dr. O’Dell.
“The long-term results of the FASTEST trial reveal that the Bioness L300 provides clinically significant and sustaining benefit in this underserved cohort of persons with foot drop,” said Keith McBride, DPT, vice president of marketing and product development. “The magnitude of the outcomes under the rigorous controls and methods of the trial will provide additional essential data to third party payers to consider for coverage of the functional electrical stimulation systems like the L300 to include persons with foot drop following stroke.”
About the L300 Foot Drop System
The award winning L300 from Bioness, Inc. provides functional electrical stimulation to the muscles of the lower leg to help lift the foot up through wireless synchronization while walking. The L300 has been cleared by the FDA to improve gait in individuals with neurological impairments such as stroke, multiple sclerosis and spinal cord injury. The L300 is used as a primary medical device to address drop foot for individuals in the community and is also used for gait rehabilitation in inpatient or outpatient rehabilitation settings to potentially realize a variety of clinical benefits including improved mobility, maintaining or increasing range of motion, re-educating muscles, the prevention or slowing of muscle loss and increased local blood flow.
About Bioness Inc.
Bioness is the leading provider of innovative technologies to help people regain mobility and independence and improve quality of life. Neurological solutions for people suffering from hand and lower extremity paralysis include the L300® Foot Drop System, L300® Plus System, and the H200® Wireless Hand Rehabilitation System which utilize functional electrical stimulation (FES) to promote motor recovery and function for individuals affected by upper motor neuron disease and injury which may include stroke, multiple sclerosis, traumatic brain injury, spinal cord injury and cerebral palsy. Patients may also benefit from the Vector Gait and Safety System®, providing over-ground gait rehabilitation through dynamic body weight support and the Bioness Integrated Therapy System (BITS™), providing touch screen software based therapy programs. Individual results vary. Consult with a qualified physician to determine if this product is right for you. Contraindications, Adverse Reactions and Precautions are available on-line at www.bioness.com
L300®, L300® Plus, H200®, Vector Gait & Safety System®, BITS™ and Bioness® are trademarks of Bioness Inc. | www.bioness.com | Rx Only
Additional information about Bioness can be found at www.bioness.com.