FDA APPROVES FIRST WEARABLE EXOSKELETON TO HELP PARAPLEGICS WALK

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By Miriam Raftery

June 27, 2014 (San Diego’s East County) --According to the U.S. Centers for Disease Control and Prevention, there are about 200,000 people in the United States living with a spinal cord injury, many of whom have complete or partial paralysis, or paraplegia. But now there is hope that some of them may soon be able to walk again.

The U.S. Food and Drug Administration has just approved marketing of  the first wearable, motorized exoskeleton  device to help people with lower body paralysis due to a spinal cord injury stand on their own two feet once again.

ReWalk is a motorized device worn over the legs and part of the upper body.  It helps a person sit, stand, and walk again with help from a trained companion, such as a spouse or home health aide.  Using a wireless remote control on the wrist, the user commands ReWalk to stand up, sit down or walk.

“This revolutionary product will have an immediate, life-changing impact on individuals with spinal cord injuries,” said Larry Jasinski, CEO of ReWalk Robotics.

Derek Herrera, a Captain in the U.S. Marine Corps, is a paraplegic trained on the ReWalk Personal System, and he will be one of the first Americans to own the ReWalk. “I see this as a milestone for people in my same situation who will now have access to this technology” Captain Herrera said.

The Marine Special Operations Command Foundation will be donating funds for a ReWalk system for Herrera, who works for the Marine Special Operations Command. “It will be incredible for me to regain independence, to use the system to walk and stand on my own,” Captain Herrera added.

ReWalk can be used by for people with paraplegia due to spinal cord injuries at levels T7 (seventh thoracic vertebra) to L5 (fifth lumbar vertebra) when accompanied by a specially trained caregiver.

It is also for people with spinal cord injuries at levels T4 to T6 where the device is limited to use in rehabilitation institutions. The device is not intended for sports or climbing stairs.  

Before being trained to use ReWalk, patients should be able to stand using an assistive standing device, or, standing frame. Their hands and shoulders should be able to support crutches or a walker. Patients should not use the device if they have a history of severe neurological injuries other than spinal cord injury or certain other medical restrictions.

Patients and their caregivers must undergo training developed by the manufacturer to learn and demonstrate proper use of the device.

To assess safety and effectiveness of ReWalk, the FDA reviewed testing and clinical data based on 30 study participants. The FDA is also requiring Argo Medical Technologies, Inc., the manufacturer of ReWalk, to complete a post-market clinical study.

The system allows independent, controlled walking while mimicking the natural gait patterns of the legs, similar to that of an able-bodied person. In addition to the ability to stand and walk independently, clinical studies of the ReWalk Rehabilitation system show significant health benefits to the user, on both a physiological and psychological level.

Study data of the ReWalk system indicates potential improvements in cardiovascular health, loss of fat tissue, and building of lean muscle mass, according to ReWalk’s manufacturer. Other potential benefits may include improved pain management and fewer hospitalizations. 

ReWalk was developed by Dr. Amit Goffer, an Israeli inventor who became a quadriplegic after an ATV accident in 1997. It was through his own personal experience in utilizing mobility devices for people with spinal cord injury that Dr. Goffer developed the ReWalk. Founded in 2001, ReWalk Robotics is now a global company with headquarters in the US, Germany, and Israel.

“ReWalking is much more than walking,” says Jeff Dykan, ReWalk’s Chairman of the Board. “ReWalk provides paralyzed individuals with the ability to stand and walk, to look someone in the eye, to hug and be hugged. These are simple acts which many of our ReWalkers thought they would never be able to do again.”

 For more information, you can visit http://www.rewalk.com


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