March 10, 2016      

The Food and Drug Administration (FDA) has given Parker Hannifin permission to market and sell its Indego exoskeleton for clinical and personal use in the United States.

More than 270,000 patients with severe spinal cord injuries in the US now have options when it comes to exoskeleton use. Prior to Indego receiving FDA clearance, ReWalk was the only FDA-cleared exoskeleton for both rehabilitation and personal use in the US.

Parker Hannifin said it will commercially launch Indego in the US in the coming months. The powered exoskeleton is already commercially available in Europe, having received the CE Mark in November 2015.

“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.”

Indego is an exoskeleton worn around the waist and legs that allows individuals with spinal cord injuries to stand and walk for up to four hours. At just 26 pounds, Indego’s design has no exposed cables or upper-body apparatus and does not require backpack mounted components. It comes in interchangeable sizes and can accommodate people from 5? 1″ to 6? 3″tall and up to 250 lbs.

The Indego mirrors natural human movements; you lean forward to initiate standing or walking and lean backward to stop and sit.

There’s even an Indego iPhone app that allows you to control operation, change settings, and capture data without the need for tethered controls. It also lets patients track session duration, walking duration, and session steps in real time, and to review and export session logs.

Podcast: How to Bring Affordable Exoskeletons to Those in Need

A recent study looked at mobility outcomes of 16 patients with spinal cord injuries who used Indego. After 5 gait training sessions (1.5 hours per session) conducted at the Shepherd Center in Atlanta, the average walking speed was 0.49 MPH for persons with C5-6 motor complete tetraphegia, 0.58 MPH for T1-8 motor complete paraplegia, and 1 MPH for T9-L1 paraplegia.

“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.”