A robotic exoskeleton, which enables individuals with spinal cord injury to stand and walk, has been given US Food and Drug Administration (FDA) clearance for clinical and personal use
Parker Hannifin's Indego exoskeleton has received FDA Clearance
Parker Hannifin said it now intends to commercially launch the Indego exoskeleton in the US as the device is already commercially available in Europe, having received the CE Mark in November 2015.
Tom Williams, chairman and CEO of Parker Hannifin, said: “For individuals who sustain spinal cord injuries, this is a milestone that could have a meaningful impact on their lives.
“In a relatively short amount of time, we have taken what was a prototype device and readied it for full commercial launch. We are excited about the future for this new growth opportunity.”
The FDA’s clearance came after the completion of the largest exoskeleton clinical trial conducted to date in the US, according to Parker Hannifin.
Gary Ulicny, president and CEO of Shepherd Center, Parker’s lead clinical partner, said: “In sponsoring such a comprehensive and landmark study, Parker demonstrated the safety and performance of the Indego technology.
“Over the course of more than 1,200 individual sessions, study participants were able to use Indego to safely walk on a variety of indoor and outdoor surfaces and settings with no serious adverse events.”
Achilleas Dorotheou, head of the human motion and control business unit for Parker, said: “This is an exciting development that will allow Indego to be more widely available.
“With the regulatory barriers addressed, we look forward to a full commercial launch of the device and further studies that will provide evidence of the economic and health benefits of exoskeleton technology.”