Wednesday, April 26, 2017
Bioness, Inc., the leading provider of cutting-edge, clinically supported rehabilitation therapies, today announced that it received CE Mark for its L300 Go™ System, a completely new functional electrical stimulation (FES) that helps increase mobility in individuals with lower limb paralysis or weakness. The L300 Go System received FDA clearance in January and now with CE certification, Bioness makes significant progress in expanding product distribution into currently serviced markets in the European Union.
Innovative L300 Go advancements help patients suffering from injuries, including foot drop and lower limb paralysis, regain control of their independence and speed the rehabilitation process. The L300 Go incorporates new features including 3D motion detection of gait events, a mobile iOS application to track user activity and numerous clinical features to reduce set-up time and improve ease-of-use.
"We are pleased to have achieved this important regulatory milestone," said Todd Cushman, President and CEO of Bioness. "The market response to the technology after its debut in February has far exceeded our expectations as clinicians realize how the L300 Go can improve clinical efficiency and facilitate superior patient care."
The L300 Go is the first functional electrical stimulation (FES) system to offer comprehensive 3D motion detection of gait events from a 3-axis gyroscope and accelerometer. Detecting movement in all three kinematic planes, patient movement is monitored and stimulation occurs exactly when needed throughout the gait cycle. A learning algorithm interprets a patient's typical movement patterns and deploys stimulation with 10 milliseconds of detecting a gait event.
The device includes the new myBioness™ mobile iOS application which allows patients to track their progress, set goals, and evaluate improvements through dynamic reporting capabilities. In addition, clinicians can precisely control the amount of dorsiflexion and inversion/eversion by using a new, proprietary electrode. Medial and lateral stimulation can be adjusted independently, providing a more efficient fitting process that saves valuable time and facilitates more productive therapy sessions.
Following a successful clinical beta evaluation, which is currently being conducted in the United States and Europe, Bioness anticipates the L300 Go will become available to European healthcare professionals and home users in late summer 2017.
About Bioness, Inc.
Bioness is the leading provider of innovative technologies helping people regain mobility and independence. Bioness solutions include implantable and external neuromodulation systems, robotic systems and software based therapy programs providing functional and therapeutic benefits for individuals affected by pain, central nervous system disorders and orthopedic injuries. Currently, Bioness offers six medical devices within its commercial portfolio which are distributed and sold on five continents and in over 40 countries worldwide. Bioness innovations have been implemented in the most prestigious and well-respected institutions around the globe with 17 of the top 20 rehabilitation hospitals in the United States currently using one or more Bioness solutions. Bioness has a singular focus on aiding large, underserved customer groups with innovative, evidence-based solutions and we will continue to develop and make commercially available new products that address the growing and changing needs of our customers. Individual results vary. Consult with a qualified physician to determine if this product is right for you. Contraindications, adverse reactions and precautions are available online at www.bioness.com.
Media Relations Contact Information
Next Step Communications
bioness@nextstepcomms.com
781.326.1741
Bioness European Office
Bioness Europe B.V.
Stationsweg 41
3331 LR Zwijndrecht, Nederland
+1 31.78.625.6088
