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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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Ticks me Off
By Reclaimer77 on 7/1/2014 11:16:14 AM , Rating: 3
This isn't some experimental drug that could kill you or cause kidney failure.

Why are we allowing the FDA to bury things like this beyond red tape and bureaucracy when people out in the world could have really benefited from it? How would it harm anyone?

This is just another wasteful Government agency struggling to appear relevant. Two years!!?? How in the hell could it take so long to evaluate this and give it your seal of approval?

This is just disgusting. The FDA is a pointless organization, end of story.




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).


RE: Ticks me Off
By retrospooty on 7/1/2014 12:12:15 PM , Rating: 2
"This is just disgusting. The FDA is a pointless organization, end of story."

While it is disgusting, as are the choices of most of the drugs the FDA rules on, the FDA has a point and serves it well...

It's just that the point isn't it's apparent public purpose. The point is money. It's there to keep the lobby/money/greasy wheels flowing in the pharmaceutical industry as well as the food production industry...


RE: Ticks me Off
By BRB29 on 7/1/2014 12:32:11 PM , Rating: 2
Some people don't realize how bad things were before the FDA was formed. Even with present day China doing the same thing as the US back then, they are still ignorant about reality. Another typical reclaimer anti-government rant.


RE: Ticks me Off
By PhallicBaldwin on 7/1/14, Rating: 0
RE: Ticks me Off
By Reclaimer77 on 7/1/14, Rating: 0
RE: Ticks me Off
By PhallicBaldwin on 7/2/2014 5:10:23 AM , Rating: 2
My "Disneyfied fantasy of these people" involves actually talking to them on a professional and personal level. Actually knowing the brilliant doctors who pass on making a huge paycheck in order to serve the global health community.

For example Dr. Anne Pariser, who is working on ways to incentivize drug companies to work on drugs that have a low chance of making them money, but a high chance of saving children's lives.

But yea...let's dismantle the FDA because it's socialism...or a paywall... or corrupt... or whatever the fuck your crazy ass thinks so we can usher in our anarcho-capitalism utopia.


RE: Ticks me Off
By ilt24 on 7/2/2014 2:54:01 PM , Rating: 2
quote:
Like delaying approval of life saving treatments for years?


That's how you choose to look at it, others might look at it as doing their jobs to make sure the produce is actually safe.

Here are some examples where the FDA did not approve something the EU did.

quote:

I. PleuraSeal to seal lung incisions was approved in the EU with minimal testing. Claimed to be superior to
stitches in preventing air leaks and subsequent lung collapse, Pleuraseal was withdrawn worldwide after a US
study showed that 3 times as many Pleura-Seal patients had air leaks as those with stitches.

II. Trilucent breast implants were approved in the EU without human testing and implanted in more than 8,000
women. After the soybean filler was found to break down into toxic compounds, causing rupture, disfigurement,
and potentially cancer and birth defects, the implants were withdrawn.

III. Stent grafts to repair aortic aneurysms made by many manufacturers were approved in the EU with limited
testing. When US approval was sought, FDA found that many of the devices approved in the EU presented
severe risks to patients, including blood clots, graft failure, and aneurysm rupture.

IV. An elbow implant was approved in the EU after FDA told the manufacturer that it had been inadequately tested
and was prone to fracture. Once marketed in the EU, many reports of implant fractures caused the manufacturer
to withdraw it

V. Cardiac constraint devices to treat heart failure were approved in the EU based on limited testing. Testing to
support US approval showed that the devices were no better than prescription drug therapy, but subjected patients
to invasive surgery, a higher risk of operative death, and precluded necessary bypass surgery for some patients.

VI. Over 160 injected dermal fillers containing poorly tested substances have been approved in the EU, causing
high rates of disfigurement, nerve damage and severe allergic reactions.

VII. The Pendra glucose monitor sensor, approved in Europe as the first noninvasive blood glucose monitoring
system, was withdrawn after later studies showed that the device was inaccurate and failed to warn of
dangerous blood sugar levels.

VIII. At least 12 PFO Occluders implanted in the heart to prevent strokes have been approved in the EU. Later
studies conducted for US approval showed that that a PFO Occluder marketed in the EU is no more effective
no more effective for stroke than blood thinning medications but, unlike blood thinning medications, cause heart
perforation and other serious complications.

IX. The CoSTAR drug-eluting stent, approved in the EU with limited testing, was withdrawn from the EU when a
study for US approval showed that patients more often need repeat procedures and suffered heart attacks with
CoSTAR than another similar available stent.

X. The Biofield device, claimed to detect breast cancer better than mammography was approved in the EU with
limited testing. FDA review showed that the company’s studies failed to demonstrate that the device did, or even
could, work. It was not marketed in the EU.

XI. RoboDoc, a robotic device to drill the femur for hip replacement, was approved in the EU with limited data.
Later studies showed that the device caused serious complications, including tendon rupture, nerve injury, and
hip implant failure.

XII. Zephyr, a valve implanted in the lung to treat emphysema, was approved in the EU to replace surgery. A
later study for US approval showed that Zephyr was no more effective than surgery, but resulted in more deaths
and serious complications.


This came from and FDA report. here is the link:

http://www.pharmamedtechbi.com/~/media/Supporting%...


RE: Ticks me Off
By Reclaimer77 on 7/2/2014 4:00:16 PM , Rating: 2
I'm shocked that a report from the FDA, would show favor toward the FDA. I mean, that's totally impartial I'm sure...

You know I could post the same exact list of things the FDA approved, and was later found to harm people, right?


RE: Ticks me Off
By ilt24 on 7/2/2014 5:03:38 PM , Rating: 2
If you say so, but in seconds I find the "URGENT MEDICAL DEVICE RECALL" for the "PleuraSeal™ Lung Sealant System" from the company Covidien.

http://www.covidien.com/recall/pages.aspx


RE: Ticks me Off
By Egglick on 7/1/2014 5:14:07 PM , Rating: 2
I think you're downplaying the risks a bit carelessly. This is a robotic suit controlled by a computer, which means that it's at risk for developing a mind of it's own. The machine could easily force the user to perform inadvertant actions, possibly even violent actions; or it could refuse to do certain tasks and hold the user hostage. Worse, it could even become diabolical and force the user to watch recent Adam Sandler movies, or trip old ladies as they walk past.

So before you go jumping to conclusions, I want you to imagine being strapped down to a machine while a robotic voice repeats "Stop hitting yourself.....stop hitting yourself".


RE: Ticks me Off
By hpglow on 7/2/2014 11:21:25 AM , Rating: 2
Don't try and apply logic to what Reclaimer has to say. He is just a mouthpeice for talk radio and fox news. Most CEOs must have installed a computer monitor at belt-buckle height so he can keep his job and type these posts at the same time.


RE: Ticks me Off
By Reclaimer77 on 7/2/2014 12:29:01 PM , Rating: 2
The guy above you is suggesting this device could become self aware like Skynet, and you're questioning MY logic??


RE: Ticks me Off
By gixser on 7/2/2014 1:19:50 AM , Rating: 2
How do you know the approval process for this version took two years? Maybe my eyes are failing me but I don't see the date the request for approval was filed being reported. All I see is a statement that a previous version was approved 2 years ago.

From 21CFR814.114 it would seem a response would be due from the FDA within 75 days for a category 3 medical device (which I'm assuming this must be due to it not, apparently, being exempted from the approval process.) It should be said this is a big assumption on my part but I'm still curious as to why you think its taken the FDA 2 years?


By mmc4587 on 7/1/2014 6:49:57 PM , Rating: 2
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...




By PhallicBaldwin on 7/2/2014 5:47:27 PM , Rating: 2
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?

http://www.nejm.org/doi/full/10.1056/NEJMsa1200223

quote:
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.


Cool.
By Monkey's Uncle on 7/1/2014 10:52:44 AM , Rating: 2
Now if I were indecently wealthy and paralyzed from the waist down I could buy one for a cool $100,000 US.

http://www.engadget.com/2010/12/06/rewalk-exoskele...




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