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Electrical-Stimulation Rehabilitation Device for Gait Impairment Accepted by FDA

February 16, 2017

The U.S. Food and Drug Administration (FDA) has authorized the use of Bioness’ L300 Go System electrical-stimulation rehabilitation device for multiple sclerosis (MS) patients and others with walking impairment.

It is the first electrical stimulation device to offer 3D motion detection of gait and muscle activation, the company says.

The L300 Go System is built upon Bioness’ NESS L300 Foot Drop System and NESS L300 Plus System. It helps children and adults with ankle dorsiflexion, or backward flexing of ankles. That is a problem for those with a condition called foot drop, or difficulty lifting the front part of the foot. The Go System also helps adults flex and extend knee muscles.

Electrical stimulation of leg muscles helps MS patients both with ankle and knee flexing, improving their walking movements.

Impaired gait gives people less control over their lower-extremity muscles, increasing the risk of a fall. Gait disorders, such as foot drop or knee instability, are frequently linked to upper motor neuron diseases such as MS, or to brain and spinal injuries.

A pioneering electrical stimulation delivery system is a key feature of the Go System. It uses data from a three-axis gyroscope and accelerometer to generate 3D motion detection of gait events and muscle activation.

The system monitors patient movement in three planes. Electrical stimulation is applied exactly when needed during the gait cycle. Changes in gait dynamics are detected within 10 milliseconds, thanks to an adaptive algorithm and a high-speed processor.

“Technological innovations including 3D motion detection and multi-channel stimulation work together to improve treatment efficiency and promote patient mobility. At Bioness, we are focused on improving the lives of patients through technology and are proud to add the L300 Go into our growing portfolio of products.” he said.

Current users of the L300 Foot Drop and L300 Plus Systems will be eligible for a Customer Loyalty Upgrade Program aimed at making the new system more accessible.

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Via MS News Today