Valencia, CA-based Bioness reported in February that it has received US Food and Drug Administration (FDA) clearance for its functional electrical stimulation device system, which includes thigh and below-knee cuffs, an in-shoe gait sensor, and a wireless control unit.
The L300 Go provides 3D motion detection of gait events and muscle activation using data from a three-axis gyroscope and accelerometer. Applications include improving ankle dorsiflexion in adult and pediatric individuals with foot drop or assisting knee flexion or extension in adult individuals with stroke or spinal cord damage.
Patient movement is monitored in all three kinematic planes, and stimulation is deployed when needed during the gait cycle. An adaptive algorithm accommodates changes in gait dynamics, and a high-speed processor deploys stimulation within 10 ms of detecting a valid gait event. The L300 also offers multichannel stimulation that allows clinicians to precisely control the amount of dorsiflexion and inversion/eversion provided and independent adjustment of medial and lateral stimulation.
Bioness will begin commercial release of the L300 Go this spring; initially it will be available only to healthcare professionals, with home user availability targeted for late 2017.