Wednesday, February 2, 2011

My Little Bone Stim

I've made no secret of the fact that I think the bone stimulator I used was responsible for the accelerated healing of my fractured metatarsal.  When buying mine, I did a lot of research on these things -- I've compiled my experiences here, in case it's helpful to others.

I note that my experience is limited to one brand of ultrasound bone stim - the Exogen 4000.  I don't know that much about any other ultrasound bone stims.   I have heard of several electrical bone stims, but I haven't had any experience with those either.

The Basics:

The Exogen 4000 is a LIPUS device -- Low Intensity Pulsed UltraSonagraphy.   It comes with a) a strap with a little hole in it; b) the unit, which has a black circular transducer attached by cord, and c) two bottles of gel (which is WAY too much).  It comes with a limited # of "charges" (more on that later), with each charge being a 20 minute session of ultrasound treatment to your injury.

It's remarkably easy to use.  Detailed instructions are here, but basically you strap it to the location of your injury, and push the one and only button on the device.  Once you do this, it runs through a system check, cycles screens showing how many times you've used the device, and then confirms that it's actually in contact with your body and has conductivity.  If it doesn't have a connection, then it turns off without expending a charge, which is nice for those times when your cat accidentally (or intentionally) steps on the button.

Then it starts its work, counting down from 20:00 to 0.  You don't feel a thing.  At the end of the 20:00, it beeps to let you know it's done.  You remove it, clean off the gel, and put it away.  Putting on the Aircast afterwards is more difficult than this thing.

I have two pro tips here:  a) mark your fracture site with a sharpie -- it will make it much easier to place the transducer correctly; b) make sure you have a paper towel or similar within reach before you strap the transducer onto your foot, so that you can clean up easily after.

How It Works:

To the best of my limited understanding, the device, by pulsing ultrasound from the transducer, applies a stimulus that causes the "upregulation" of genes, promoting faster action by the body's healing processes, including removal of dead tissue and growth of new bone, capillaries, etc.  Smith & Nephew's discussion of this process is here.   I'm not quite sure what "upregulation" is, but it sounds effective, and I suspect that there are politicians that oppose it.

The area of the pulse is supposedly about 2.5 times the size of the transducer (which is in the shape of a quarter, and is approximately a centimeter thick).   So, you don't have a large area of effect, and you need to get the transducer as close to the fracture as possible.   For this reason, the Exogen is best used on bones that are close to the surface; and those who are larger may be more limited in the areas of the body where the Exogen will be effective.   And if you have a cast, you'll have to have a window cut within your cast.

I used the device on a metatarsal bone, which is in my foot and just below the skin.   The strap to hold the transducer in place fit easily around my foot.   However, the strap is small enough that I don't believe it would fit around my thigh.   Thus, any use of the bone stim for bones other than those in hands, feet, lower leg, or arms is going to require jury-rigging something to hold the transducer in place for 20 minutes.


The clinical trials all were based on one use per day, and so that's what the recommendation is.   I've heard from different sources that most sales reps recommend using it twice a day, spaced as evenly as possible (the idea being that you apply the stimulus, and then allow the body to react, so it doesn't make sense to queue up your uses back to back).   As I note below, I used mine 3 times a day, at 8 hour intervals, with no ill effect.

Limited Charges:

The Exogen 4000 comes with a guaranteed 150 uses, aka "charges", according to their patient brochure (link to pdf).  In practice, you can likely get many more -- I'm currently on use 200, and I've read reports of others getting 250 or more uses.  But, you can only count on 150, so you want to be judicious in your use of the device.  I do note that the PDF linked above implies that you can send the device back to Smith & Nephew for more charges if you're still healing your injury, but my sense is that that only holds true if you buy the device directly from S & N (as opposed to the Ebay/Craigslist option).

I also understand that the battery life is also limited by time, with approximately a year of battery life before the device fails.   Mine is still going strong, but since it was manufactured in 2/10, I'll be putting battery life to the test shortly.

Insurance coverage:

As a general rule, insurance companies have different criteria for whether they'll cover LIPUS, based on whether your fracture is fresh, or some time has passed since your fracture.  Quite a few insurers post their coverage memoranda on-line, so that you can dig it up (albeit with some effort).  Here's a few that I found.  I do note that many distinguish between "fractures" and "stress fractures" - I'm not sure what the criteria is there.
  • Anthem - For fresh, they'll cover fractures of the middle of the tibia, a "Colles Fracture" of the wrist, closed fractures that are at high risk for non-healing due to vascular issues and soft tissue/vascular damage, and closed fractures for people that are at "high risk", including smokers, diabetics, anemics, steroid users, the obese, the nutritionally deficient, and alcoholics.  Yes, there's a bit of irony here, as well as disappointment that training-obsessed runners aren't considered high-risk. 
    Otherwise, if you wait 45 days and your fracture hasn't progressed, and you meet certain other criteria, they may cover.  Stress fracture? Specifically excluded.
  • BCBS-Delaware - looks like they'll cover fresh closed fractures, as well as fractures that have shown no sign of healing for 3 months (except for skull and spine, and see other limitations).  They don't cover stress fractures. 
  • Cigna - for fresh, they'll cover fractures of the middle of the tibia, a "Colles Fracture" of the wrist, or closed fractures where there's a high risk of not healing due to either poor blood supply or "comorbidities" like "smoking, diabetes, renal disease, or other metabolic disease where bone healing is likely to be compromised".  If you've gone more than 3 months without healing, and it's not your skull or vertebrae, then they may also cover it (see other conditions).   If your stress fracture has gone 90 days without healing, but can be seen by imaging, they should cover as well.
So, Your Insurance Doesn't Cover It.  What Now?  

Well, the answer is actually pretty obvious.  EBAY!   There's generally at least 20-30 of these babies up for sale at any time.   And it's really not that bad a deal.

The Exogen 4000 is generally priced at about $4000 to the insurers -- if you have a 10% copay for durable medical equipment, that's $400 out of your pocket.  Of course, in exchange for that, you get a brand new device that's under warranty, and the peace of mind that comes from supporting our nation's pharmaceutical/medical research industry.

Or, there's the world of online auctions - the devices seem to be priced for about $200-400 on eBay.   You are taking a risk by buying a used device online, but at least the hit to your pocket will be the same or less.  There is an excellent guide to buying these things on eBay that is worth reading.  I will briefly note two things to look for/ask about:
  1. The number of charges left on the device.  As noted above, these do come with a limited # of charges.  You should be able to assume 150 charges; you may get many many more out of the specific device, but why risk it by buying a device with 145 charges?  The seller should be able to provide a photo of the start up screen showing the number of full and half uses -- if s/he doesn't, I'd buy elsewhere.
  2. The age of the device.  Supposedly, these have a limited shelf life too -- the battery ages.  Also, there was a FDA recall on these in 2008-2009; it's probably a good idea to avoid those.  You can identify the age of the device clearly by the serial #, as explained here.  Again, if the seller won't provide the serial #, don't deal with him/her.
Of course, all the other caveats about buying on eBay apply.  Look for sellers that answer questions promptly, that can provide detailed information about the device, and that have a long history (over time) of good ratings.  Even then, there's still an element of risk, and people desperately looking for any means to heal their bones faster are likely easy marks.  Caveat Emptor.

My Experience:

On November 3, I was diagnosed with a traumatic spiral fracture of the second metatarsal on my left foot -- the fracture clearly showed on x-ray, and was NOT a stress fracture as traditionally seen (stress fractures have a gradual onset, are splintery rather than a clean break, and often don't show on x-ray; mine was a sudden clean fracture that was immediately visible). 

My podiatrist recommended this device pretty strongly, and placed me in touch with a representative from Smith & Nephew who was charged with trying to get my insurance to cover the device for me.   After 3-4 days passed without her returning my calls, and I had confirmed via my own research that my insurance was very unlikely to cover, I went the eBay route, and purchased one with 29 uses on the counter for $340, plus $20 to overnight it.

As noted above, the official literature recommends that you use the device once a day; I had read multiple comments on various message boards indicating that sales reps advise to use it twice a day.  When I asked my podiatrist how often to use, he responded "the more the better."

With that advice in mind, I used three times a day, with 8 hour intervals -- 5:00 am, 1:00 pm, and 9:00 pm.  I would fudge the exact timing a bit -- sometimes 1:00 pm would be 12:30 or 1:30 -- but I consistently used it three times a day seven days a week up until the day I was told the bone was healed, and I was cleared to run.

Since them, I've still been "zapping" my foot once a day -- I don't know whether this is accomplishing anything, but it can't hurt.

I was originally projected for 12 weeks before the bone would be healed sufficiently to run; in the end, I was cleared to run at 7 weeks.  This is consistent with the "best case" predictions for results of a 38% reduction in healing time (patient brochure pdf, p.26).

Can I be sure the bone stim reduced my healing time?  No.  There's no way I'll ever know.  But I think my $360 was money very well spent, and I'd make the same decision the next time around.



Addendum -  some interesting links:

  • http://www.engadget.com/2006/07/25/portable-bone-healing-system-gets-fda-nod/
  • http://www.cafepharma.com/boards/showthread.php?t=271986
  • http://www.google.com/cse?cx=partner-pub-8687477133452597%3Ay2r7jtxdt15&ie=ISO-8859-1&q=exogen+4000&sa.x=0&sa.y=0&sa=go&siteurl=www.letsrun.com%2Fforum%2Fflat_read.php%3Fthread%3D3071261
  • http://forums.studentdoctor.net/archive/index.php/t-625872.html

    46 comments:

    1. thanks for the report! Hopefully, we'll never need to utilize this stim ever again! ;)

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    2. Sooooooo glad you posted this. Very thorough and helpful. I am going to ask my doctor about it if it turns out I have a stress fracture. I am also pretty sure that this device is made using the quality control software that my company develops!

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    3. I am so interested in this whole bone stim thing. I am keeping my fingers crossed that I won't have a need for it ever, but I will bookmark this page just in case. Thanks for such a thorough review!

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    4. Oh, interesting. So are you selling yours now? :-) I am with Cigna and have a ridiculously high deductible, so...

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    5. Awesome article! Thanks just started using mine Feb. 25 2012...and they sure do offer waaay tooo much gel...ha! Thanks again..John

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    6. Going the eBay route make sure you get a picture of the counter and serial number on the back,it tells the month and year it was made. Also when it dies between 150-250 uses that's it no charger, this company does this so they have to service you. They will only service original owner. Also taking the battery out and doing it yourself will ruin the circuit board. Good luck

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    7. i have my exogen 4000 strapped on as i type.i find out in two weeks, when i go to get my cast removed if it worked.if it didnt then i have to get surgery done. so im hoping your right and that it works.

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    8. I live in germany and here it is very hard to get ahold of this device since insurances don't pay for it and my doctors didn't recommend it at all. so I also bought one via ebay form the US and had it shipped to germany (quite expensive 300$ for the device + 140$ shipping + 140$ customs) and now after not even 130 uses the system just beeped constantly (battery dead)...now the good news to everybody that worries about buying one with old battery, you can exchange the main battery pack. the easiest way would be to buy an exchange pack over osi-batteries (around 30$) but I wanted it to be as quick as possible and so I bought 5 new 3.6 Volt 2.1 Ah lithium batteries and soldered them onto the original battery circuit board (be careful because lithium batteries may explode if you expose the wrong sides to too much heat) make sure you don't touch the "watch" battery inside the system, this powers the memory and kills the main unit once disconnected (so don't touch). now after I have my new custom made battery pack everything works fine again

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      1. You said you replaced the battery? I have purchased a battery from OSI and was wondering how to get into the unit. It seems simple enough but someone had posted that if you try to fix it yourself you will damage the circuit board. any suggestions

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    9. Thank you for posting up your story! I came across your blog through a Google search. I was debating whether the cost was justified, as my doctor has recommended a bone stimulator for my foot (fracture to a metatarsal-tarsal coalition).

      I like that you give a lot of very useful information as well as tell us your story. It makes me feel a lot better about spending the money. Love your sense of humor too. :)

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    10. My son has a stress fracture in hiw lateral condyle at the end of the femur. Ortho recommended rest and evaluation in 6 weeks, this type of fractures can take 3 to 6 months to heal. After 4 weeks and only minor progress on healing, I bought an exogen 4000 on line for only $100.00. It was a gamble, the machine had starting serial number of 0210, which meant it was from february of 2010. Based on what I had read, batteries are only guaranteed for up to a year and can not be replaced. The owner of the machine told it still turned on and only had 57 uses, wich meant that I could still get about 100 uses out of it. I got it the next day from the seller, and it did turn on an immediatley started using on my son. You can't tell if its working, because he does not feel anything when its on. In a week he has improved dramatically, he can put alot more pressure on the leg and could jog without pain, we are going to give it another week of treating it with 3 sessions per day and try to sprint next week.... to usm it all up, the exogen is worth a shot if you are frustrated with your healing progress.

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    11. I bought an Exogen 4000 on line as well with the same battery warning. I got about 100 uses out of it and the company said it would not replace the battery at any price. Since I had nothing to lose I ripped the case open, found a simple battery that had a code on it. Typed in the code and a company came up that sold the battery for 60 bucks. Bought it, put it in and whammo, back in business. http://www.atbatt.com/?gclid=CLuZuo-Jj7QCFal7QgodKE8ALQ

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      1. Willam: Glad to hear that. I accidently purshed a battery for about the same price thinking I was buying the exogen 4000. I will do the same once battery goes out on my machine. How difficult was it to open up the device?

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      2. Not too difficult. There are two screws behind the label. You can either pull off the label which will damage the printing, or just drill through it where the round screw holes are. The battery is easy to change as there is a quick connect wired to the 5 cell assembly. There is also a button battery inside. I suspect that you could kill the exogen by removing it.

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    12. if you buy one, be sure it is sanitized professionally. You dont want a staph infection on top of your fracture.
      Also, keep in mind you do not get a manufacturer warranty unless you are the first prescribed buyer of the unit. Further, messing with the batteries is a bad idea. Do you really want to use a ultra sound machine that you have torn apart. I guess you can rent these at www.exogenrental.com
      That may be the best bet
      Good luck with your recovery!

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    13. Who owns exogenrental? The insurance companies nor the manufactuer rents these devices because they are "Single Patient use Only." Any one claiming to rent exogen units at this time, is most likely doing it fraudently.

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      Replies
      1. I believe exogenrental.com is a safe site, and a legitimate. I have seen their sanitation facility, and they offer a waranty.

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    14. My unit says 52...does that mean its only been used 52 times or has 52 treatments left?

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    15. it means that it has been used only 52 times! lucky you! Mine died this morning in my treatment 169!!!!

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    16. Is anyone using the bine stimulator more than once a day. My rep told me to use it once a day, which I have done for the last 30 days with some healing. The fifth metatarsal fracture has not fully joined yet.

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    17. hi - i was diagnosed with a jones fracture on my 5th metatarsal on june 6 --- I'm 36 year old female --- rolled my foot over a rock in central park while running the loop --- picked up my exogen bone stimulator at the hospital on 6/29. I think I will start using it 2x a day. There will be a long gap between xrays. My last xrays taken on 6/20 looked the similar to the ones taken on 6/6. I have my next xray appointment on 7/19 ---- I am hoping for good news.

      Anyone else have positive results with this device??

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    18. I have a personal question, I have the same situation were you working, are you able to work with the treatment did you apply for disability?

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    19. I just completed my 83rd tx. At the one month mark my OS said he did not see any improvement. I don't want summer surgery so I am continuing to use my Exogen until end of summer with hopes that it will make a difference. I am 9 months post broken left distal fibula, no surgery. I bought my Exogen new through sales rep. My insurance covered all but 900$ so its an expensive item. From what my OS said, he would not have been able to order one for me and get it covered until I was 6 months past the fracture date which is when a non-union is diagnosed. I guess before that it is called a delayed union! I would so love this thing to work. I have used it twice daily except the past week or so I have been out a lot and did it only once.

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    20. I got mine thru Medicare yesterday and spent 3 hours surfing today for info. This is BY FAR the BEST advise I have found.
      Thank you very much.
      I broke my knee cap into 4 pieces from a car accident 03-21-13, had 2 pins inserted and the 3 lower pieces (about 20% of my knee) broke from the pins (the 80% upper piece) the end of May. The 2nd surgery was 06-06 with my knee cap wrapped in wires around, thru and over the top. It looks like a rebar mat in bridge construction.
      At my 2nd post surgery visit last week the doc didn't like the healing progress and recommended the Exogen with once a day use. But the 66 yo construction superintendent asked the rep if twice a day is better and she agreed. So here I am doing 12 hour intervals. I hope it works.

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    21. I have a like brand new Exogen 4000+ System that was used by my Mother only 7 times. She had broken her Femur at the age of 87. After surgery, she was told to use this system-- which she did. The only problem: she was not taking a blood thinner after surgery and developed a blood clot which lodged in her lungs and she passed away. This unit is like brand new and I would love for someone who needs one to have this one. I have been told that it could sell for upwards of $800 b/c of it's condition; however, I will sell it for $500 if anyone is interested. The Provider can bill the Insurance Companies up to $4000 for this unit even tho it's value is capped at $1500!

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      1. How should we contact you to discuss?

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      2. Is your Exogen 4000 still available. I will buy it for $600.

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    22. What do you think the risk is purchasing a used one from 2006 with only 27 treatments and 0 partial treatments? The asking price is $349.
      Thanks

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      Replies
      1. That is a 7 or so year battery... ?? Not too confident with that price and that age...

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    23. As much info as their is on the net, nothing quite like your testimonial here - thank you very much it is very helpful as I look to recover!! Written very well, and I like your style... hope you have continued to stay healthy and healed up :)

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    24. The battery life seems variable based on one ebayer I communicated with.
      They may or may not assure you the unit will even turn on when it is delivered.
      If I need it for 3 months, and it dies after 5 days where does that leave me

      I have found I can rent one at www.exogenrental.com

      The guarantee the unit to work for the rental time frame or will replace it.

      I believe my credit card company will help me if I have problems and this does not hold true.

      I plan to submit to my insurance for reimbursement, not sure how that will work.

      My accountant says that if I don't get reimbursed I can take the funds from my health savings account.

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      1. hi, Did this website end up being legit and work for you? Please let me know, I would love to use it as well.

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      2. I went to exogenrentals.com and saw on their rental form page that they would be closed through March 24th. This was on June 10th. I tried to send a message on their Contact Us page, but the CAPTCHA would not accept any of my entries. They don't seem to be in business anymore.

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    25. This technology goes back around a 100 years, beginning with electromagnetic and electrical stimulators.

      I hada Jones break in my metatarsal in 2010 and was issued a device, even with the device healing took 6 months. I have used many of the remaining charges for different friends, mot recently a broken humorous which has healed nearly completely in about a month (his Dr. hasn't been told and is astonished at the speed.)

      At the time I got mine, that $4000 price in the USA was $1500 in the UK.

      Most companies would approve them only for slow healing breaks at that tie, which meant for most breaks you first had to show no healing for 6-8 weeks--which eliminates the main advantage of rapid healing.

      Rapidly healing the break allows for faster recovery of the muscles and tendons.

      Were the machines in routine use, they would save the USA millions of man-hours of recovery time and billions of dollars.

      The devices are quite simple, the complexity is in software which controls the frequencies used and the pulse rates.

      The biggest advantage of the ultrasonic versions seems to be the short treatment time.

      At any rate, mine is nearing 150 after 2 years and so far the battery is holding fine, I am looking for a way to recharge the device as it has proven useful for several people to date.

      In addition to the machine, I added minerals to my diet along with vitamin D3 to ensure that the required materials for reconstruction of the bone were plentiful.

      In theory it ought to be useful for soft-tissue healing too, but so far as I know, no testing has been done.

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    26. Thank you for posting this as a very depressed runner with a stress fracture this sheds some hope that my doctor did not provide. Hope you are doing well.

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    27. it is likely to crack. This normally occurs in healthy and fit individuals who subject their body to excess physical activities. This kind of fracture is normally experienced by sportspersons and military recruits who engage in physical activities for long periods of time. They develop a stress fracture that leads to foot pain. The second situation is where people have extremely weak bones. This commonly affects women with osteoporosis.

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    28. I wonder if using the Exogen 5x a day would be too much?

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    29. I crushed my toe to where I needed cadaver bone used as a glue to adhere the bone so it would heal correctly. The doc said I would not get my pin out for 8 weeks. I used the bone stim religiously every day for 5 weeks (had to wait a week for the wrap to come off and expose skin) and he took the pin out in 6 weeks instead of 8. The rep for the bone stim told me when I bought it that it could improve healing time by 2 weeks and it did exactly that. Totally worth it when you have a break in a bone.

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    30. To be exact, I used it for the recommended 20 minutes once a day. The doc tells me that I no longer need to use it but I think I will continue anyway just in case it helps. The studies show that once the bone is adhered, the stim does no more good. But who knows?

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    31. Yes, thanks for this info! I didn't know they had these devices for feet, but I have used a similar device for my neck fusion. I tried to give my device back to the company so someone else could benefit, but they can take it back and said my doctors cannot use it for another patient either, but that is a shame. I think I will offer it online to someone who does not have insurance coverage....thanks again! TP in michigan

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    32. For what its worth we rented a Exogen machine from www.exogenrental.com
      for my mother in law, It arrived in two days.
      Hopefully, it will get her back on her feet and out and about.

      Just wanted to mention they are definitely in business, and were very quick to reply to my emails , answer my questions and deliver the rented contraption.

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    33. Thanks for the great review. It seems wrong that a company can make these devices with such planned obselence (ie they are designed to fail soley so the manufacturer can make more money) without concern for the environment or waste. Also the technology is simple and has been around for a long time, they probably cost around $50 to manufacture, I don't know why there are not more brands on the market as it appears to be a monopoly.
      Just one question, is it the number of uses that causes the shutdown, or is it simply that the battery expires? If its just the battery any good technician (and I could also do this myself) can solder a new battery in.

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    34. Please can anyone offer advice about Exogenrental.com? I am in touch, but afraid to make a mistake. Has anyone used this successfully for rental of the Exogen 4000?

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      1. I am renting from them now. They are a legit company. Device was shipped day after I ordered it and arrived in good working condition.

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    35. I had wonderful experience with the exogen 4000 helping to heal fractured ankles. I no longer need my device...its in excellent clean condition. ..from year 2010....says 6 full uses..1 partial use...almost two full bottles of gel and I'm willing to sell for $125...22992299a @ g mail dot com

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