Therapy Areas: Devices
ReWalk Robotics Ltd wins US FDA clearance for ReStore soft exo-suit system for stroke survivors with mobility challenges across the US
5 June 2019 -

Medical device company ReWalk Robotics Ltd (Nasdaq:RWLK) reported on Tuesday the receipt of clearance from the US Food and Drug Administration (FDA) for the sale of its ReStore soft exo-suit system for use in stroke survivors with mobility challenges across the rehabilitation centres in the US.

Stroke is a leading cause of disability, which affects approximately 17m people worldwide each year and as many as 80% of people who have had a stroke will suffer from gait impairments.

The company had successfully completed a multi-centre clinical study of the ReStore system across five of the country's leading rehabilitation centers. This data was submitted to the US FDA in ReStore's 510(k) submission and plans to publish the results of the clinical study later this year.

According to the company, the patented soft exo-suit technology was developed at Harvard University's Wyss Institute for Biologically Inspired Engineering.The ReStore system underwent initial clinical testing and demonstrated its potential to improve walking for stroke survivors.

In conjunction, the ReStore system is comprised of a soft, garment-like design that connects to a lightweight waist pack and mechanical cables that help lift the patient's affected leg in synchronized timing with their natural walking pattern. The system provides targeted assistance to the patient, provides the physical therapists with extensive data during gait training as well as informs strategies to optimize a patient's treatment and progress using real-time analytics, said the company.

To date, the company has placed nearly 550 exoskeletons in 26 countries and trained more than 270 rehabilitation clinics to conduct exoskeleton training worldwide.