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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 (FDA) finally approved 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 already approved 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.

ReWalk w/ Obama
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.

ReWalk FDA Approval

Spinal injuries are unquestionably one of the most terrible types of physical affliction.  According to a 2013 paper in Nature 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 (WHO) offers a slightly higher estimate -- 250,000 to 500,000 per year.
 
The European Federation of Pharmaceutical Industries and Associates (EFPIA) offers a crude estimate 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 between 200,000 and 310,000 Americans.  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)
  • Spastic movements
  • Chronic pain
  • Loss of bowel/bladder function
  • Urinary tract infections
  • Loss of muscle tone
  • Obesity
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 its statistics, 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 Patient
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 walker (basically, FNS+IRGO) have been gaining traction.

Spinal Rehab
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 Patient
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.

Sources: FDA [press release], ReWalk [press release]



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RE: Ticks me Off
By Hakuryu on 7/1/2014 11:52:11 AM , Rating: 2
Companies are only out to make money. Without the FDA, we'd be flooded with snake oil salesmen.

Perhaps this 'suit' could do further damage; hence the reason it is only approved for certain damaged areas along the spine. Someone with a damaged spine above the approved region could further complicate their issue with a heavy battery backpack for example.

But let's deregulate everything so we can get things now, no matter what problems may arise in the future. Worked really well for the housing market.


RE: Ticks me Off
By retrospooty on 7/1/2014 12:15:51 PM , Rating: 2
"Companies are only out to make money. Without the FDA, we'd be flooded with snake oil salesmen."

What you are referring to is the "idea" of the FDA. That is the public designed intent of the FDA, but in actuality, the FDA just turns out to be another corrupt organization built on payoffs and exploiting the taxpayers. Useful drugs are stopped if the right people aren't paid off, and harmful chems are allowed into our food when the right people are paid off. THAT is the FDA.


RE: Ticks me Off
By Reclaimer77 on 7/1/2014 12:28:51 PM , Rating: 3
I love when people use the blanket "Companies are only out to make money". As if the Government is employed by charity workers...

At least companies produce a product and contribute to economic development. The salary of every non-military Government employee is just a drain on everyone, a total waste.


RE: Ticks me Off
By FaaR on 7/1/14, Rating: 0
RE: Ticks me Off
By Reclaimer77 on 7/1/2014 4:46:45 PM , Rating: 2
How is that a troll post? You know what, all the time on Daily Tech people are criticizing America compared to Europe. Can you explain to me why EU citizens were enjoying this product two goddamn years ago, while in America we have to wait two years for the FDA to "approve" (legalized extortion payola) this device?

I'm not entirely apposed to some sort of process where risky drugs are evaluated, don't get me wrong. But how in the hell can it realistically take TWO YEARS to approve this? Come on, that's just an unacceptable time frame. I want to see it, in writing, that someone worked on this every day, for two years. I want to see what was done. How much it cost. Show me some evidence!

This should have been fast-tracked or at least made some kind of priority. With the freaking budget the FDA has? You have to be kidding me if you think two years after Europe is acceptable.


RE: Ticks me Off
By prophet001 on 7/2/2014 8:20:31 AM , Rating: 2
I would imagine it took two years because it was held to a higher standard than what the European Union held it to.

What sort of backlash do you think would be caused if this thing malfunctioned and dropped someone into a pool?


RE: Ticks me Off
By cruisin3style on 7/2/2014 10:42:51 AM , Rating: 2
that's right

the economy is so good now, we should lay off all government employees, who don't spend any of their income anyway so they have no impact on the economy

this would have a double bonus effect of allowing the president and congress to run the country themselves, literally. i love the idea that they would be taken down a peg or two by spending their time making their own coffee and printing out their own bills, instead of using all their time to run the country


RE: Ticks me Off
By hpglow on 7/2/2014 11:13:17 AM , Rating: 2
We already have snake oil salesmen they are called the supplement industry, and you can thank reclaimers party for deregulating supplements in 1994. The FDA only does this amount of feet dragging on products comming from companies that don't pay enough bribe money. Simular to the the house and congress work with "contributions", and lobbying (ie leagal bribes).


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