PR Newswire03.26.18
Bioness Inc., provider of cutting-edge, clinically supported rehabilitation therapies, announced that it received clearance from the U.S. Food and Drug Administration (FDA) for the myBioness mobile app for use with the L300 Go System.
The new myBioness mobile iOS application allows home users to control their L300 Go system including ability to change stimulation modes between gait and training along with adjusting personal pre-set intensities to meet their daily activity demands. The app has been designed to keep users engaged in the rehabilitation process and motivated to meet their recovery goals with ability to track activity, set personal goals and review their progress over time using dynamic reporting capabilities.
Gait movement disorders, such as foot drop and knee instability, are often associated with an upper motor neuron disease such as stroke and multiple sclerosis as well as injuries to the brain and spinal cord. Individuals with an impaired gait have less control over their lower extremity muscles and are at an increased risk for falls. The L300 Go is the first functional electrical stimulation (FES) system to offer 3D motion detection of gait events and muscle activation using data from a 3-axis gyroscope and accelerometer. Patient movement is monitored in all three kinematic planes and stimulation is deployed precisely when needed during the gait cycle. An adaptive, learning algorithm accommodates changes in gait dynamics, and a high speed processor that deploys stimulation within 10 milliseconds of detecting a valid gait event. This rapid, reliable response is critical and supports user confidence.
"Technological innovations including 3D motion detection and multi-channel stimulation work together to improve treatment efficiency and promote patient mobility," said Todd Cushman, president and CEO of Bioness. "At Bioness, we are focused on improving the lives of patients through technology and are proud to add the myBioness mobile application to the L300 Go portfolio of products."
The L300 Go System was cleared by the U.S. Food and Drug Administration on January 27, 2017 with formal approval of the upgraded mobile application clearance dated March 9, 2018. The system is indicated to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait.
Bioness will begin commercial release of the myBioness mobile app in the spring of 2018. The L300 Go Systems are commercially available since the summer of 2017.
The new myBioness mobile iOS application allows home users to control their L300 Go system including ability to change stimulation modes between gait and training along with adjusting personal pre-set intensities to meet their daily activity demands. The app has been designed to keep users engaged in the rehabilitation process and motivated to meet their recovery goals with ability to track activity, set personal goals and review their progress over time using dynamic reporting capabilities.
Gait movement disorders, such as foot drop and knee instability, are often associated with an upper motor neuron disease such as stroke and multiple sclerosis as well as injuries to the brain and spinal cord. Individuals with an impaired gait have less control over their lower extremity muscles and are at an increased risk for falls. The L300 Go is the first functional electrical stimulation (FES) system to offer 3D motion detection of gait events and muscle activation using data from a 3-axis gyroscope and accelerometer. Patient movement is monitored in all three kinematic planes and stimulation is deployed precisely when needed during the gait cycle. An adaptive, learning algorithm accommodates changes in gait dynamics, and a high speed processor that deploys stimulation within 10 milliseconds of detecting a valid gait event. This rapid, reliable response is critical and supports user confidence.
"Technological innovations including 3D motion detection and multi-channel stimulation work together to improve treatment efficiency and promote patient mobility," said Todd Cushman, president and CEO of Bioness. "At Bioness, we are focused on improving the lives of patients through technology and are proud to add the myBioness mobile application to the L300 Go portfolio of products."
The L300 Go System was cleared by the U.S. Food and Drug Administration on January 27, 2017 with formal approval of the upgraded mobile application clearance dated March 9, 2018. The system is indicated to provide ankle dorsiflexion in adult and pediatric individuals with foot drop and/or assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait.
Bioness will begin commercial release of the myBioness mobile app in the spring of 2018. The L300 Go Systems are commercially available since the summer of 2017.