Americans Finally Permitted to Use ReWalk Exoskeleton at Home by FDA
July 1, 2014 10:04 AM
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(Source: Argo Medical)
Europeans enjoyed use for last two years, have enjoyed marked improvement in standard of living
On Thursday (6/26) the
U.S. Food and Drug Administration
the ReWalk-P system for home and personal use. Produced by Israel's
Argo Medical Technologies Ltd.
, this wearable robotic leggings, backpack, and wearable smartwatch-style mode control allows people with partial paralysis to stand, walk, and even climb stairs again without the spasticity, discomfort, and other limitations of traditional alternatives.
The FDA had
a slightly different version of the device -- the ReWalk-I -- for use in clinics back in 2012, one of only two exosuits to receive such approval. The Rewalk-P -- the home use model -- is the first such exosuit to be FDA approved.
I. Spinal Injuries -- Global and U.S. Prevalence
While some exosuits are focused on rehabilitating patients with muscle weakness or increasing the strength of healthy humans for military, industrial, or construction purposes, Argo Medical's focus is more singular -- it wants to treat paralysis. While stem cells (i.e. lab-grown spines) are clearly the superior solution in the long term, in the short term Argo Medical has committed to delivering a product that will give paralyzed users more mobility at a relatively low cost compared to powered wheelchairs.
The first ReWalk user, a wounded Israeli veteran, gets a visit from Israeli PM Benjamin Netanyahu and U.S. President Barack Obam [Image Source: ReWalk]
The ReWalk-P's FDA approval thus -- at this point -- only covers those with spinal core injuries (SCIs), or more specifically paraplegia. Under the new FDA approval, the ReWalk is only approved for home use for those with lower spinal injuries (in the T7 (thoracic) vertebrae through the L5 vertebrae (lumbar)). In those with mid-spine injuries (T4-T6 (thoracic) vertebrae) it remains only approved for use at rehabilitation clinics in the U.S.
Spinal injuries are unquestionably one of the most terrible types of physical affliction. According to
a 2013 paper
that combined known statistics with advanced modeling, it's estimated that between 133,000 and 226,000 spinal injuries occur per year.
The World Health Organization
a slightly higher estimate
-- 250,000 to 500,000 per year.
The European Federation of Pharmaceutical Industries and Associates
(EFPIA) offers a
that about 2 million people globally are living with serious SCIs. Roughly 80 percent are male -- typically due to males' higher participation in athletics and violent conflicts. According to most estimates, over half of people with an SCI are classified as paraplegic; so over 1 million people may be living worldwide with paraplegia.
In developed countries like the U.S., traffic accidents are the most frequent cause, followed by falls. In developing regions like Africa and the Middle East violence is often a cause.
In the U.S. various estimates place the population living with a traumatic SCI at anywhere
. Of these, an
estimated 11,000 people per year
become paraplegics in the U.S. About 45-50 percent of those who incur an SCI, according to various estimates, become paraplegics. That's as many as 150,000 Americans, or roughly 1 in every 2,000 Americans.
II. A Costly Disease Gets an Unprecedented Treatment
While paraplegics typically still have the use of their arms, the disease causes a number of serious complications ranging from loss of sexual function, digestive problems, bladder control issues, and depression. Many of the negative affects are linked to the loss of the ability to stand and walk. Among the maladies associated with loss of walking are:
Pressure sores (often known as "bed sores")
Osteoporosis (weakening of the bones)
Thrombosis (blood clots)
Heart disease (e.g. higher "bad" cholesterol)
Loss of bowel/bladder function
Urinary tract infections
Loss of muscle tone
Another indirect problem is cost. Founded by actor Christopher Reeve, who was paralyzed in 1995 while horseback riding, the
Christopher & Dana Reeve Foundation
has served as an advocate for the disabled on this issue. According to
, on average a paraplegic paralysis results in roughly half a million dollars in hospital bills.
Each additional year of life incurs another $66,000 in costs for treating the above health problems, attending physical therapy and driving wheelchairs. Other
more conservative estimates
place the cost of the initial hospitalization at around a quarter million and estimate around $28,000 USD in annual costs.
Paraplegic patients face a challenging and costly outlook. [Image Source: Jochen Sands]
The average paraplegic in the U.S. is paralyzed at age 29. At that age, it is estimated that the cost of treating the disease for the rest of their life will be around $2M USD.
A very good wheelchair costs between $15,000 and $20,000 USD, but insurance typically only covers around $6,000 USD of that cost. Aside from treating resulting illnesses, the rest of the cost goes to expensive rehabilitation devices such as automated treadmills and mechanical walking apparatus for rehab centers. An automated treadmill cost around €300,000 (~$410,000 USD) in 2008.
Off the treadmill, traditionally isocentric reciprocating gait orthosis (IRGO) -- a mostly mechanical precursor to the exosuit --
was typically used
for further rehabilitation. More recently
functional neuro-stimulation (FNS) with a walker or a hybrid neuroprothesis (HNP) with a walke
r (basically, FNS+IRGO) have been gaining traction.
Traditional walking devices and even the more exotic electrical stimulation can prove painful and or dangerous. [Image Source: VA.gov]
But the hardware for all of these approaches remain expensive and the dropout rate among patients remains high. Many patients struggle to take steps with these kinds of devices and also suffer upper body pain while walking. Another cause of dropout is that the electric stimulation can lead to new spastic movement disorders. These disorders can sometimes become severe and dangerous enough a patient must stop their rehab work.
Other costs tend to be more subtle. At the time of their accident 58.8 percent of people are employed with the remainder being either homemakers, students, retired, or unemployed in a traditional sense at the time of their accident. Given the mobility difficulties only 34.4 percent of paraplegics still are employed 8 years after their accident. That indicates over 40 percent of people who have a job when they're paralyzed lose it in under a decade. This exacerbates the cost issues as they often lose employer-provided insurance.
ReWalk may allow patients to go well beyond traditional physical therapy. By making them more mobile it may cut back on the typical job loss and relationship struggles associated with even paraplegia. [Image Source:medizin-und-technik.de]
Paralysis patients are also more likely to remain single if not married at the time of their accident and are more likely to get divorced. In both cases, this can bring financial hardship for those who manage to keep their job (e.g. lack of tax credits and potential child support costs).
The Rewalk-I -- like traditional rehab devices -- did little for patients in terms of making them more ready to experience normal social interactions and to be able to navigate at their workplace. But the newly improved ReWalk-P can allow a paralysis victim to walk around at work (almost) like normal and allows them to see eye to eye with potential mates, a key psychological factor in interpersonal relationships.
FDA [press release]
ReWalk [press release]
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Food and Drug Administration Government Bureaucracy
7/1/2014 6:49:57 PM
Prosthetics are not Food.
Prosthetics are not Drugs.
The FDA has no business legislating prosthetics.
Oh, and just so the rest of you are aware...
the FDA does a _iss poor job regulating Food and Drugs too...
And for those of you afraid of "snake oil"...
I have lived in countries where they don't have an FDA, and guess what?
People listen to Doctors... and exercise something called FREEDOM of CHOICE.
Sometimes I am ashamed of all the people wearing Freedom Flags on July 4th... seems to me the USA is now the land of the oppressed... because we are too afraid of liberty.
Land of the Free,
Home of the Brave...
RE: Food and Drug Administration Government Bureaucracy
7/2/2014 5:47:27 PM
Yes. Nothing says traitor to your country like funding research for the safety of medical devices and food under a central agency.<picture of bald eagle shedding single tear>
So where is this wonderful place without any food and drug regulations? Couldn't be in Europe because they have the EMA. Canada has The Food Directorate, Mexico has the SSA...about 60 other countries use the FDA's guidelines.
...and what's this? According to the most prestigious medical journal the FDA is on average faster than Europe and Canada for approving drugs...all the while maintaining a better safety record than both?
People listen to Doctors
...and who do you think doctor's listen to? I'll give you a hint...starts with an F...FDA! That's right! They base their decisions off of the research done by their colleagues at the FDA.
You could learn all of these things by simply speaking to your PHP instead of reading websites about how the government is coming to take your freedoms.
"What would I do? I'd shut it down and give the money back to the shareholders." -- Michael Dell, after being asked what to do with Apple Computer in 1997
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