Another Robotic Suit

Well, actually, it is the latest version of a company’s exoskeleton.

I just read the article and saw the video on YahooNews. I went to the ReWalk website and learned more about it. It says that ReWalk is the first exoskeleton to receive FDA clearance for personal and rehabilitation use in the United States. Then I noticed that the Stair Function is currently not available in the United States.

It appears to be designed for spinal cord injuries. It also mentions rehab for stroke victims and people with Multiple sclerosis. Yet, in the FAQ Section, it mentions that people with ALS, Cerebral palsy, Traumatic brain injury, etc. can use it. So, it might be something for those of us living with Kennedy's Disease.

ReWalk has over eighty training centers in the United States and hundreds more throughout the world. I don’t know what it costs, but it appears some insurance companies and the V.A. are using it for rehab purposes.

It appears there are three different units. I grabbed this from the article. "The lightweight, small, wearable suit is much simpler than ReWalk’s device that enables paralyzed patients to stand, walk and navigate stairs. Unlike the ReWalk 6.0, which includes robotic leg attachments that can weigh nearly 50 pounds, the soft exoskeleton looks more like the harness construction workers wear for safety than a bionic system. It consists of a waist belt fitted with a motor and battery, flexible cables that transmit power from the motor to the ankles, leg braces and shoe sensors. And it’s all activated by the flick of a switch.

ReWalk has not yet determined how much the soft-exoskeleton suit will cost, but says it will be more affordable than the ReWalk 6.0, which has a list price of $77,000."

Who can use it?

Before using the device, confirm that the following prerequisites are met by the user:

• Hands and shoulders can support crutches or a walker
• Healthy bone density
• Skeleton does not suffer from any fractures
• Able to stand using a device such as EasyStand
• In general good health
• Height is between 160 cm and 190 cm (5′ 3″ – 6′ 2″)
• Weight does not exceed 100 kg (220 lbs)

People with the following conditions should not use the ReWalk™:

• History of severe neurological injuries other than SCI (MS, CP, ALS, TBI etc)
• Severe concurrent medical diseases: infections, circulatory, heart or lung, pressure sores
• Severe spasticity (Ashworth 4)
• Unstable spine or unhealed limbs or pelvic fractures
• Heterotopic ossification
• Significant contractures
• Psychiatric or cognitive situations that may interfere with proper operation of the device
• Pregnancy

Bionic Suit cleared by FDA for home use

The below article by Bionics Research is a major step forward for individuals with spinal chord injuries.  It is also important for people living with a progressive neuro-muscular disorder like Kennedy's Disease.  The more of these units the hit the market, the lower the cost.  It also allows for even greater testing and generates interest in the technology.world for similar units that will support other uses.

ReWalk™ Bionic Suit

Personal Exoskeleton System Cleared by FDA for Home Use

Revolutionary technology that allows individuals with Spinal Cord Injury, such as paraplegia, to stand & walk receives clearance for personal use in the U.S.

Marlborough, MA—June 26, 2014 — Exoskeleton leader ReWalk Robotics announced today that the U.S. Food and Drug Administration has cleared the company’s ReWalk Personal System for use at home and in the community. ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with Spinal Cord Injury (SCI) to stand upright and walk. ReWalk, the only exoskeleton with FDA clearance via clinical studies and extensive performance testing for personal use, is now available throughout the United States.

The FDA has issued a marketing clearance for the ReWalk, which was granted via a rigorous de novo process that involved multiple clinical studies demonstrating safety and effectiveness of the technology.
“This revolutionary product will have an immediate, life-changing impact on individuals with spinal cord injuries,” said Larry Jasinski, CEO of ReWalk Robotics. “For the first time individuals with paraplegia will be able to take home this exoskeleton technology, use it every day and maximize on the physiological and psychological benefits we have observed in clinical trials,” he added. “This is truly the beginning of ‘ReWalking’ as a daily reality in the U.S.”

[Read more:  http://bionicsresearch.com/ ]