Bioness L300 Go Rehab System Wins CE Mark

Bioness Inc., a provider of clinically supported rehabilitation therapies, 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.