The latest news and information about what's going on with SCI science and research. Brought to you by Sam Maddox, author of the Christopher & Dana Reeve Foundation Paralysis Resource Guide.

Second Exoskeleton On The Market

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A second exoskeleton model that allows people with paralysis to stand up and ambulate has been approved for personal use by the FDA. The Indego, developed at Vanderbilt University and licensed to the Parker Hannifin Corporation, should be available later this year. It’s been available in Europe since November.
 
The Indego follows the ReWalk system, which was approved in mid-2014. Indego was cleared, says the company, “after completion of the largest exoskeleton clinical trail conducted in the United States.” According to a Parker news release, “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.”
 
The main advantage of the Indego appears to be that it weighs 26 lbs., about half of what the ReWalk weighs. The Indego unit is also said to doff and don faster than the ReWalk. There is little difference, at least to my eye, as far as performance. Neither exoskeleton is fluid or natural looking; the robots must be used with forearm crutches to keep one’s balance while standing and walking. They are generally useful only on flat, smooth surfaces.
 
The ReWalk is now selling for around the price of an entry level Maserati, about $70,000. The Indego is even more, at $80k. I don’t know about you but that seems like a lot of dough for a little bit of upright mobility – and with either model, a full regimen of physical therapy and rehab is a must. There’s a tiny market of self-pay paraplegics that may be able to afford this, but the companies are hopeful that insurance will pay. Indeed, in December the VA agreed to reimburse ReWalks for veterans with spinal cord injuries.
 
From ReWalk:
Our transition from a self-pay driven-model to a more robust reimbursement strategy is beginning to deliver results. Multiple ReWalkers were able to secure coverage and two denials were successfully reversed on appeal in the U.S. and Germany as a result of our investment in strategic reimbursement. We generated 801 qualified leads during the year and have 128 pending claims. As these continue to grow, we are confident that our efforts will result in additional positive coverage decisions,” stated Larry Jasinski, Chief Executive Officer.
 
ReWalk announced in a recent press release that a private insurance company had agreed to pay “following the ruling of an external independent review organization that overturned the health plan's initial denial of coverage” for one of its units for a spinal cord injured surgeon in the Northeast part of the U.S. No other details were provided except that the devise was approved as “medically necessary,” however that was defined.
 
The first exoskeleton marketed in the U.S. was the Exso, which remains restricted to clinical use. There are several other models coming soon, including HAL (Hybrid Assistive Limb) from Japan, which is approved in Europe and is said to have an eye on the pediatric market. A unit called the Phoenix, from SuitX in Berkeley, California, is lighter, at 27 lbs., and cheaper, although it’s hard to say $40k is a bargain. Rex Bionics, in the U.K., is working on a commercial exoskeleton that is hands-free.
 
I’m wondering, with all the competition and a relatively small population of potential users, has anyone done what a reasonable marketer would do, to ask the question: Does anyone now using a wheelchair really want an exoskeleton? I’ve said this before, until they become lighter and less conspicuous, they’re a pricey novelty.
 
So is Medicare going to go for this? That’s the first question investors want to know. If these devices are sold as an exercise modality, forget it, exoskeletons won’t get covered. Medical necessity? Prove it. The exoskeleton companies have been saying there is much more to these robots than walking. They mention of bowel and bladder improvement, and also better bone density and reduced spasticity. And there is the difficult-to-measure psychological benefit of looking eye to eye with people at parties. Other than some presentations at medical meetings, there is nothing in the medical literature to affirm that robot assisted ambulation improves any other aspect of paralysis. As part of Indego’s plan, Parker says it will run a clinical trial with 24 participants, designed to determine whether regular use of the device will improve other SCI conditions.
 
Safety is an issue with any device that stands or walks a paraplegic. I haven’t heard of problems with ReWalk, but the company hasn’t been doing the follow-up it promised. ReWalk got slapped last week with a demand for data from users from the FDA claiming that the company’s approval requires them to show the device is safe and that people weren’t getting hurt by falling.
 
From an FDA release:
The FDA reviewed the ReWalk through its de novo classification process, a regulatory pathway for novel, first-of-its-kind medical devices that are generally low-to moderate-risk. The FDA is requiring Argo Medical Technologies, Inc., the manufacturer of ReWalk, to complete a post-market clinical study that will consist of a registry to collect data on adverse events related to the use of the ReWalk device and prospectively and systematically assess the adequacy of its training program.
 
Anyway, ReWalk’s stock shares took a tumble on the FDA news, and now here comes competition from Indego.

Michael Goldfarb is the mechanical engineering professor at Vanderbilt who developed the newly released robotic legs. This is the first product from his Center for Intelligent Mechatronics lab to become a commercial product. From a Vanderbilt press release:
“You can think of our exoskeleton as a Segway with legs. If the person wearing it leans forward, he moves forward. If he leans back and holds that position for a few seconds, he sits down. When he is sitting down, if he leans forward and holds that position for a few seconds, then he stands up,” Goldfarb said.
 
Initial development for the Indego came from The National Institute of Child Health and Human Development. Parker Hannifin, a global giant with 55,000 employees that did $55 billion in sales last year, picked up the Indego's license in 2012.
 
 
Posted by Sam Maddox on Mar 15, 2016 12:01 PM America/New_York

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