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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 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 "PleuraSealâ„¢ Lung Sealant System" from the company Covidien.

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


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