The claim examiner’s task of reserving for future medical care is becoming more complex by the day. It is hard to even imagine what medical science will have to offer injured workers even a few years down the road. For example, Vanderbilt University just announced that the FDA has given clearance to market and sell the powered lower-limb exoskeleton created by a team of Vanderbilt engineers and commercialized by the Parker Hannifin Corporation for both clinical and personal use in the United States.
Indego®, which allows people paralyzed below the waist to stand up and walk, is the result of an intensive, 10-year effort. The initial development was funded by a grant from the National Institute of Child Health and Human Development. In 2012 Parker, a global leader in motion and control technologies, purchased an exclusive license to market the design and has worked closely with the Vanderbilt group to develop a commercial version of the medical device.
Until recently “wearable robots” like Indego were the stuff of science fiction. In the last 15 years, however, advances in robotics, microelectronics, battery and electric motor technologies have made it practical to develop them to aid people with stroke and spinal cord injuries. The device acts like an external skeleton. It straps in tightly around the torso. Rigid supports are strapped to the legs and extend from the hip to the knee and from the knee to the foot. The hip and knee joints are driven by computer-controlled electric motors powered by advanced batteries. Patients use the powered apparatus with walkers or forearm crutches to maintain their balance.
“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” one of the engineers said.
Indego is the second exoskeleton to receive FDA certification for U.S. use. The first was a device produced by Rewalk Robotics Ltd. However, Indego’s clearance came after completion of the largest exoskeleton clinical trail conducted in the United States. According to the 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.”
One of the design goals was to give users the maximum amount of personal freedom possible. One of his requirements, for example, was to allow the user to put the exoskeleton on and take it off while sitting in a wheelchair. As a result, the Indego is considerably lighter and less bulky than the other exoskeletons under development.
Beginning this summer, the scientists will head a four-year U.S. Department of Defense-funded study of the tangible economic and rehabilitation benefits of exoskeletons for people with spinal cord injuries. This will be performed at three medical centers: James Haley Veteran’s Hospital in Tampa (the first VA center in the country to use Indego), the Mayo Clinic in Rochester, Minnesota and the Vanderbilt University Medical Center.
People who use wheelchairs regularly can develop serious problems with their urinary, respiratory, cardiovascular and digestive systems, as well as getting osteoporosis, pressure sores, blood clots and other afflictions associated with lack of mobility. The risk for developing these conditions can be reduced considerably by regularly standing, moving and exercising their lower limbs. The study, which will involve 24 participants, is designed to determine whether regular use of the Indego will also reduce these conditions.
Indego has been available in Europe since November, when it received the CE Mark, the European Union’s equivalent of FDA approval. The initial price is $80,000. The next step is getting the device approved for health insurance reimbursement. This involves getting the Centers for Medicare and Medicaid Services (CMS) to approve a “rate code” for the exoskeleton: a numeric code that identifies the characteristics of patients who Medicare/Medicaid will reimburse for purchasing a given piece of medical equipment. Typically, the government will reimburse 80 percent of the cost of approved medical devices. In most cases private health insurance providers adopt the CMS code.