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|FDA Clears Parker’s Indego® Exoskeleton for Clinical, Personal Use|
“For individuals who sustain spinal cord injuries, this is a milestone that could have a meaningful impact on their lives,” said Tom Williams, chairman and CEO of Parker Hannifin. “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 United States.
“In sponsoring such a comprehensive and landmark study, Parker demonstrated the safety and performance of the Indego technology,” said Gary Ulicny, Ph.D., president and CEO of Shepherd Center, Parker’s lead clinical partner. “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.”
“This is an exciting development that will allow Indego to be more widely available,” added Achilleas Dorotheou, head of the human motion and control business unit for Parker. “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.”
Indego is a robotic exoskeleton or powered orthotic device that allows users to stand and walk and holds great promise for affording people with paraplegia a new level of independence.
To learn more about Indego, visit www.indego.com.
With annual sales of approximately
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