Parker Hannifin robotic exoskeleton wins FDA nod for personal, clinical use by paraplegics

Indego exoskeleton in use--Courtesy of Indego

Major industrial motion and control company Parker Hannifin ($PH) has gained FDA clearance for its Indego exoskeleton to be used by paraplegics in clinical and personal settings. It can be used for mobility in paraplegics or for rehabilitation in patients with lower limb injuries. The news comes just after competitor ReWalk Robotic Technologies ($RWLK) has had a setback with regulators on safety concerns about its exoskeleton.

Still, at a cost of $80,000 in the U.S., the Indego is scarcely a viable option for most who might need it. But reimbursement help may be forthcoming. Late last year, the U.S. Veteran's Administration committed to paying for a similar exoskeleton from competitor ReWalk, which has a comparable price tag. Parker already has on ongoing four-year supply deal for a U.S. Department of Defense study of the Indego's economic and rehabilitation benefits at three rehab centers that dates back to last October.

Last week, ReWalk received a warning letter from FDA regarding concerns that its exoskeleton could lead to falls and serious injuries or death.

The Indego can be used by patients who are 5' 1'' to 6' 3'' and weigh up to 250 lbs. It is not intended for stair climbing, which could limit its usefulness in everyday life--or, more obviously, for playing sports.

At a weight of 27 pounds, Indego is about half the weight of the comparable ReWalk device, which weighs in at 51 lbs. Of the ReWalk's total weight, 5 lbs comes from an accompanying backpack that must be worn. The Indego device already gained a CE mark last November and is marketed in Europe.

Indego exoskeleton--Courtesy of Indego

"For individuals who sustain spinal cord injuries, this is a milestone that could have a meaningful impact on their lives," said Parker Hannifin chairman and CEO Tom Williams in statement. "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 company said it completed the largest exoskeleton clinical trial to date in the U.S. for Indego with more than 1,200 individual sessions in indoor and outdoor settings on various surfaces that resulted in no serious adverse events.

Concluded 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."

Parker Hannifin mostly is focused on industrial applications of motion and control tech across a variety of businesses including aerospace, climate control, electromechanical, filtration, fluid and gas handling, hydraulics, pneumatics, process control as well as sealing and shielding. The $14+ billion company doesn't have the singular focus that dedicated startup ReWalk does for its exoskeleton, but it does have vast engineering expertise and resources to draw upon to support its Indego.

- here is the announcement