June 29, 2014
FDA Approves ReWalk Motorized Exoskeleton For Sale In The US
Alan McStravick for redOrbit.com - Your Universe Online
This year's FIFA World Cup, being played in Brazil, is a quadrennial event that captures the attentions of a staggering majority of the people that live on this planet. Excusing the pun, the event kicked off by celebrating a revolutionary advancement in paraplegic mobility technology made possible by work done by one of Brazil's native sons, Dr. Miguel A. L. Nicolelis, MD, PhD.
Duke University-based Nicolelis and his Walk Again Project enabled 29-year-old paraplegic Juliano Pinto to launch the biggest sporting event on Earth by donning the exoskeleton and willing it to move with the power of his mind, kicking out the first ball to officially begin the World Cup almost three weeks ago.
While news of this amazing prototype was welcomed the world over, equally good news was announced this week for individuals living with paralysis in the United States. That is because the US Food and Drug Administration (FDA) has now cleared for marketing and sale a motorized exoskeleton called ReWalk.
This bionic suit first gained attention just over two years ago when Britain's Claire Lomas became the first person to complete a marathon while wearing an assistive motorized device, reports CNET's Dana Kerr. Lomas finished the 2012 London Marathon in 16 days time. This is an impressive feat for someone who previously was unable to move due to a severe spinal cord injury.
ReWalk was designed to enable its wearer the ability to stand, walk and navigate stairs with limited assistance. In a statement heralding the FDA announcement, director of the Office of Device Evaluation, Christy Foreman stated, “Along with physical therapy, training, and assistance from a caregiver, these individuals may be able to use these devices to walk again in their homes and in their communities.”
ReWalk, developed by Argo Medical Technologies of Marlborough, MA, was subjected to a standard de novo classification process by the FDA. This process is used for all devices that are novel in design and intended use. The FDA also put ReWalk through the ringer, testing all aspects of its hardware and software as well as its battery systems and overall durability. Aiding in the final decision to approve the device for sale was clinical data obtained from 30 participants currently using the device.
As noted above, ReWalk has already jumped the regulatory hurdles in Europe and has been available for the purchase price of about $70,000 US. That will be the anticipated price of the device here in the US once it goes on sale as well. Once made available, Argo Medical Technologies will be required to provide to the FDA a post-market clinical study that highlights specifically any adverse events as a result of use of the device.
As reported by the USA Today, Marine Capt. Derek Herrera, a paraplegic trained on the device, will be one of the first Americans to own one.
"I see this as a milestone for people in my same situation," Herrera said in an Argo Medical Technologies press statement. "It will be incredible for me to regain independence, to use the system to walk and stand on my own."