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ReWalk(TM) Personal Exoskeleton System Approved by FDA for Home Use
MARLBOROUGH, Mass., June 27, 2014 /PRNewswire/ --Â 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 throughoutthe
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.Â
"This revolutionary product will have an immediate, life-changing impact on
individuals with spinal cord injuries," saidLarry 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."
Derek Herrera, a Captain in the U.S. Marine Corps, is a paraplegic trained on
the ReWalk Personal System, and 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 - to experience walking again, and all of the
health benefits that come with ReWalking," Captain Herrera said. The Marine
Special Operations Command Foundation (MARSOC Foundation) will be donating the
funds for Herrera's ReWalk system; Herrera 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," he added.
ReWalk provides user-initiated mobility through the integration of a wearable
brace support, a computer-based control system and motion sensors. 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, building of lean muscle mass, and
improved bowel function. Feedback from ReWalk users supports these potential
benefits and others, such as better pain management, fewer medications, and
potentially reduced hospitalizations.
"What makes this so exciting is the understanding that, in addition to the
psychological benefits realized by ReWalking, consumers are able to improve
upon the clinical benefits," said Jasinski. "Now, with FDA clearance, users
will continue to experience these benefits on a daily basis at home."
ReWalk has been tested extensively in the U.S., Europe, and Israel. The
ReWalk system is supported by the most published data of all exoskeleton
systems in the rehabilitation market, and is used by more people worldwide than
all other exoskeleton systems combined.
ReWalk was developed by Dr. Amit Goffer, an Israeli inventor who became
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.
The company offers two products: ReWalk Personal and the ReWalk
Rehabilitation wearable robotic systems. The ReWalk Personal System, designed
for everyday use by individuals at home and in their communities, is custom-fit
for each user. The system is designed for daily use in a range of environments
such as in the home, at work, at social events, indoors as well as outdoors, as
well as on different surfaces or terrains. This revolutionary, cutting-edge
technology allows users to stand, turn and walk with independent control of the
system.
The ReWalk Rehabilitation system is used in the clinical rehabilitation
environment, where it provides a valuable means of exercise and therapy as well
as a training base for individuals to be certified, enabling them to purchase a
Personal system.
"The person walks the system, the system does not walk them. The users are
in control -- when they want to sit, they sit, when then want to stand and
walk, they do so," said ReWalk inventor Dr. Goffer.
"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," he
added. "When you take that into account in addition to the health benefits, it
underscores just how monumental a day this is for the SCI community here in the
U.S."
The ReWalk Personal System is available to consumers upon meeting
requirements from a medical examination and successful completion of the
required training program. The company also offers a comprehensive maintenance
and warranty program for the system.
SOURCE ReWalk Robotics
ReWalk Robotics
Web Site: http://www.rewalk.com
ReWalk(TM) Personal Exoskeleton System Approved by FDA for Home Use
MARLBOROUGH, Mass., June 27, 2014 /PRNewswire/ --Â 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 throughoutthe
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.Â
"This revolutionary product will have an immediate, life-changing impact on
individuals with spinal cord injuries," saidLarry 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."
Derek Herrera, a Captain in the U.S. Marine Corps, is a paraplegic trained on
the ReWalk Personal System, and 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 - to experience walking again, and all of the
health benefits that come with ReWalking," Captain Herrera said. The Marine
Special Operations Command Foundation (MARSOC Foundation) will be donating the
funds for Herrera's ReWalk system; Herrera 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," he added.
ReWalk provides user-initiated mobility through the integration of a wearable
brace support, a computer-based control system and motion sensors. 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, building of lean muscle mass, and
improved bowel function. Feedback from ReWalk users supports these potential
benefits and others, such as better pain management, fewer medications, and
potentially reduced hospitalizations.
"What makes this so exciting is the understanding that, in addition to the
psychological benefits realized by ReWalking, consumers are able to improve
upon the clinical benefits," said Jasinski. "Now, with FDA clearance, users
will continue to experience these benefits on a daily basis at home."
ReWalk has been tested extensively in the U.S., Europe, and Israel. The
ReWalk system is supported by the most published data of all exoskeleton
systems in the rehabilitation market, and is used by more people worldwide than
all other exoskeleton systems combined.
ReWalk was developed by Dr. Amit Goffer, an Israeli inventor who became
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.
The company offers two products: ReWalk Personal and the ReWalk
Rehabilitation wearable robotic systems. The ReWalk Personal System, designed
for everyday use by individuals at home and in their communities, is custom-fit
for each user. The system is designed for daily use in a range of environments
such as in the home, at work, at social events, indoors as well as outdoors, as
well as on different surfaces or terrains. This revolutionary, cutting-edge
technology allows users to stand, turn and walk with independent control of the
system.
The ReWalk Rehabilitation system is used in the clinical rehabilitation
environment, where it provides a valuable means of exercise and therapy as well
as a training base for individuals to be certified, enabling them to purchase a
Personal system.
"The person walks the system, the system does not walk them. The users are
in control -- when they want to sit, they sit, when then want to stand and
walk, they do so," said ReWalk inventor Dr. Goffer.
"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," he
added. "When you take that into account in addition to the health benefits, it
underscores just how monumental a day this is for the SCI community here in the
U.S."
The ReWalk Personal System is available to consumers upon meeting
requirements from a medical examination and successful completion of the
required training program. The company also offers a comprehensive maintenance
and warranty program for the system.
SOURCE ReWalk Robotics
ReWalk Robotics
Web Site: http://www.rewalk.com