Thursday, June 2, 2011

Hot Fun in the Summer Time

End of the Spring and here she comes back
Hi, HI, Hi, there
Them summer days, those summer days

That's when I had most of my fun, back
high, high, high, high there
Those summer days, those summer days

On cloud nine when I want to, Out of school, yeah
County Fair in the country sun, and everything it's true, ooh yeah
Hot Fun in the Summertime

Yes, fellow bloggers to quote Sly & the Family Stone, as the spring winds down, another summer of hot fun lies around the corner.  It will be interesting to see what a new season will bring the industry.  Yesterday's announcement that Mike Mogul has taken the CEO position at DJO is another sign that one should expect the unexpected.  After a stellar twenty-two years at his beloved Stryker, Mike has decided to move on.  One of the good guys in the industry, Mogul has survived more changes than Lady Gaga.  But what does it say about this chameleon?  Could this mean that there will be additions by subtraction at Stryker?  Who'd thunk it that M2 would ever leave Stryker? His replacement, spit shined and polished right out of the J&J playbook. One doesn't need to hear Les Cross sing Mike's praises.  One company's loss is another company's gain.

On a much lighter note, let's monitor how the Integra and Sea Spine acquisition and merger unfolds.  Bloggers have to be entertained when an "effusive" Stu Essig is quoted as saying "Sea Spine is an ideal strategic fit for Integra, as the combination brings two well-respected innovators in the spinal fusion market." C'mon Stu, you may be able to soft-shoe your friends on the Street with your Aztec-Two Step, but let's get serious, those in the industry are not some gullible analyst.  If innovation equates acquiring two companies known for commodity products, TSB must admit, you definitely epitomize innovation. Essentially, you hopefully bought into a market.  Word on the Street in Vegas was that you couldn't give the product away in the City that could never pass up a fusion that they didn't like. Name one product in your portfolio that would equate to being best in class?  By the way, whatever happened to that tortured baboon?

Now onto something more serious.  Readers have wanted a discussion on Interspinous Process Devices.  The current crop of products come in all shapes and sizes.  So which products have the optimal design? Which system has the exceptional instrumentation?  Is Lanx and Medtronic leading the pack when it comes to market share?  So here they are, and if there are any that we have missed our apologies, but we're sure someone will inform us of a potential faux pas.

Lanx - Aspen
Medtronic - XStop
Globus - Flexus
Paradigm - Coflex
X-Spine - AXLE
Life Spine - (Updating the website would help)
Vertiflex - Superion (What happened to Moti)
Osteomed - PrimaLOK SP

86 comments:

  1. Don't forget MSD - Spire
    Globus - SP Fix

    SP clamps with teeth

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  2. Barbaric devices. No results. Just a fad

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  3. 4:39 is that an old quote about pedicle screws from 1980's??

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  4. What about the Affix plate from Nuvasive or the "ILIF" procedure?

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  5. From a long time device guy, now not in that side of the biz, and now in the biz of looking at this stuff, some folks and I have given about all ISP devices, both fusion and stabilization devices a pretty good look.

    Like all devices, in the right patient, they work. Trick is finding the right patient, and sometimes, that is a guess. Good part is, if the guess in wrong, for the most part very little damage is done allowing for alternatives.

    In general, not particularly impressed with any of the spacers. Blocking motion at one level doesn't do good things at the adjacent levels, and is too often a long run for a short slide. Except for Coflex, and the Wallace (not available in the US), none really address translation, and that can be important in a less the stable spines.

    The fusion devices seems to be working better than most would expect. Again, patient selection is key, and good interbody stabilization is a must. Of the devices out there for fusion, though a bit bigger than the others, OsteoMed's seem to really conform best to the ISP and can get closer to the lamina than others, has the best chance of securely hooking up L5-S1, and instrument wise is fine. Lanx is the leader, and they do quite well, can address L5-S1 a good percentage of the time and seem to have the best instrument package.

    Question is, would you allow any of them to be put in your back vs. pedicle screws and rods. And, yes I would. OsteoMed for sure, Lanx above L5,

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  6. OsteoMed design does allow for better anatomical fit and seating onto bone than the rigid uniaxial Lanx device. But Lanx does have the marketshare so far. OsteoMed will be picked up within a year or two,
    Lanx ?? it's a sinking ship..

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  7. What role will surgeon reimbursement play in whether he or she chooses a fusion ISP or a non-fusion ISP (Coflex or XSTOP)? Why would someone ever use Coflex or XSTOP when they can make a lot more money doing a fusion spacer? Sucks for the guys who invested all that money in IDE studies for non-fusion.

    When will the day come that payors no longer pay for ISP spacers for fusion?

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  8. The Integra team is here in CA this week to properly introduce themselves to the Seaspine team.

    They are trying to give the impression of cooperation.

    I wonder how long that will last before both corporate and distributor jobs are phased out?

    Don't be fooled Seaspine, they bought you and they are sharpening the knives as we speak.

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  9. Question is- Do ISP fusion devices really fuse to the spinous process? Any studies out there?

    Interventional Spine (Renew) ISP allograft seems like another facet dowel propaganda. No 510k required. HA-HA

    6:50 - Changes will come in cycles. Gotta keep moral up for the little people.

    P.S. Moti who?

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  10. These devices are for stabilization or to decompress the nerve roots by opening the foramen.

    They do not Fuse the spine.

    How about uni lateral ped screws/TLIF with stabilizing SP Plate ?

    Will that work for stabilization until the spine fuses?

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  11. Talk about running up the tab...

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  12. Spacers are just another fad for those looking for "the next big thing" in spine.

    Clinically speaking they provide no benefit to patients.

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  13. 8:29

    What's the point of the interspinous device if your doing a TLIF and uni-lateral screws already? Seems like overkill (probably the point of the post above).

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  14. 6:50,

    Sharpening their knives to phase out distributor jobs?

    It's hard to sell a product without a distribution network. Can you elaborate on your assertion?

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  15. Interspinous devices were tried in France (Bordeaux) in the 1990s, and abandoned once the long term results were in. Long term meaning more than 2 years. Once again, America insists on repeating the stupid mistakes made by others. That's called arrogance.

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  16. ISP fusion devices are here to stay. They perform the well documented decompression of the x stop with the permanence of a fusion. The surgery is quick, easy, and bills well for the surgeon. If it doesnt work you can always come back with pedicle screws later.

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  17. DON'T FORGET! SpineFrontier's VEGA INSPAN

    http://www.spinefrontier.com/resources/inspan_trifold.pdf

    Now in a hospital near you.........

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  18. spine frontier keep barking! Like all the rest

    Dyingspine- no need to update look at aspen it is identical

    axle-waste of time 50 other people in ever market selling it

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  19. Physician reimbursement will drive adoption, whether it is legit or not. Same reason the screw fixated interbody devices have taken off. Surgeons have found a way to make the same money as they get for a plated ACDF and can do it in less time.

    Why not add an interspinous fusion device to your TLIF or your XLIF? Less time than screws, less cost to the hospital, and good reimbursement for the surgeon.

    For those trying to play in the non-fusion interspinous market, game over...surgeons don't make enough money on the CPT code in place compared to fusions.

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  20. Osteomed has never done a spine product before and it shows.
    The primalok is too bulky and over-engineered.

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  21. 12:12, too bulky? Compared to what, other ISP fusion devices or pedicle screws and rods. Because if that's your reference, it's not a good arguement. If compared to other ISP fusion devices, it is bigger, but also sets lower and therefore is contained in the tissue. I have seen Aspen, when used at 5-1, tent the skin and at the upper levels positioned high on the ISP, which someone pointed out, was an issue with the early devices in Europe - had ISP fractures. As far as over engineering, at least they have done some. All others are pretty simple and very universal. And, as we too often find out, something universal does not work universally.

    As far as reimbursement, docs don't earn much for doing spacers, and the reimbursement for fusion has just been dropped to similar to sub-laminar wiring. But, it's a pretty short surgical time, they still get the interbody codes and can get lateral bone graft fusion. And it appears, there will be action similar to the cervical spine where codes will be combined for interbody and stabilization (could of happened already, just haven't seen the communication).

    Please know, I have no relationship with OsteoMed, or Lanx or any other ISP device. But, I do there is further development around them for fusion and the outcomes are favorable. Pedicle screws have not changed and have had no competition.

    With a re-operation rate quoted by a number of 3rd party payers of 19 - 25%, finding an alternative for a significant percentage of the spine population that provides better outcomes is good for all of us vs. the continuous negative press we get from the government watch dogs like Grassley and Deyo, the New York Times, and 3rd party payers.

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  22. I am just a rep but there are a lot of so called "experts" on here. How many of you have done an ISP procedure, tracked the results and used imaging modalities to assess the fusion of an ISP device? As a rep that has the pleasure of working with a surgeon that has put in many of these devices in I can tell you that patients do very well and fuse. I have read the chart notes, spoken to some of the patients and seen CT scanx and xrays demonstrating fusion. With most decompressions a surgeon is invariably creating instability, which was part of the problem to begin with. A straight decompression will further destabilize a spine segment and speed up the degenerative cascade. Lumbar fusion results leave a lot to be desired for and I see the ISP device as a reasonable and conservative step before a traditional screw and interbody fusion procedure. I would want it done and you would too if you have seen and or performed both.

    As far as Integra I distribute them as well and know first hand the good, the bad and the ugly. Although they may not have any, "best in class" products they do have many good me too products, which is the same as everybody else as far as I am concerned. I also think the job "Stu" has done building Integra into a billion dollar company is good if not remarkable. They have many problems and issues but it is not "Stu" or their products. I would love to go on about their problems but I have exceeded my word count and interest in educating the uneducated further.

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  23. 2:16 PM

    OHHHHH you are soooooo much more than rep (as you state). You are my idol!!!!

    Can I have your autograph???

    Please don't break your arm patting yourself on your back!!!

    XOXOXOXOX

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  24. Stuie is that your PR guy singing your praise, come out we know its you

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  25. 2:16 May consider himself just a "rep", but I'd like everyone to know that I think of myself as an "expert" as 2:16 notes.

    Should anyone on here have any questions on this or any other topic, please feel free to post them and I will provide all of the right answers.

    All the best,
    Mr. Know-it-all

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  26. I wonder why none of the top five companies have jumped on the fusion ISP bandwagon (yet). Synthes, JNJ, Zimmer, Stryker, and Orthofix don't have anything. Medtronic has the old Spire, which is a plate-only system that doesn't really compete in this space.

    Fusion ISPs are probably the fastest growing non-biologic product category in spine. You would think the big guys would want to get in on the action.

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  27. 3:13 Why bother to innovate when there are many acquisition targets? As for your post, Synthes is now part of J&J, who will simply buy the technology as they are prone to do,,

    Zimmer is a joke.

    Stryker & Orthofix are eyeing up several of the companies mentioned above.

    Regards,
    Mr. Know it all

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  28. 2:16

    Please recite the product, white paper or clinical data you speak of. Perhaps fusing in space or optical illusion? (Holding breath……….….exhale)

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  29. 3:18
    Synthes is not officially part of J&J yet. The companies still operate individually.

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  30. 3:13,

    Are you seriously calling Zimmer a "big boy" in spine? They haven't developed their own tech other than Dynesis and PF2 in the last 5 years have they?

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  31. 3:53 "YET"? It is only a matter of time now,,

    Safe to assume that you work for Synthes and are holidng on to every last shred of hope that the deal doesn't go through for some reason?

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  32. ISP fusions are a joke and Laynx has the lead right up until the DOJ slams all of their paid bitchboys for Medicare fraud. Fusion via ISP has NO data to support it is as even close to traditional fusion techniques. As stated, it's only used in lieu of motion preservation devices because it pays much better. And as was mentioned earlier they do very little harm going in meaning when these patients come back for a proper fusion they are not likely to sue because they were told in their consult this was a risk. All of these "fusion" devices are terrified of real data as they would see their reimbursement disappear in quick order.

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  33. 2:16 I like ur style unless we caught you in the middle of yoga;)

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  34. 4:56 said: "And as was mentioned earlier they do very little harm going in meaning when these patients come back for a proper fusion they are not likely to sue because they were told in their consult this was a risk."

    That's just funny.

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  35. Correction- 3:18- I like your style. I'm a rookie...

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  36. ISP device equals laziness. Yes I have one in my bag and do well with it, but if it were me i'd rather have a proper fuision and get it right the first time.

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  37. Dear 3;18,

    I never stated I had clinical data or a white paper to support my position, which begs the question if I did would your reading comprehension skills enable you to process the data. Since you brought it up I would like to know if you have white papers, clinical data and/or randomized, double-blinded prospective peer reviewed data to support your products? I will let you in on a little secret, no one does in spine. It is kind of difficult to test your product versus a placebo or another product that was really designed for a different patient, indication and pathology.

    4:56 I don't think anyone is terrified of comparing themselves to "real data" about fusions. Fusions inherently have many problems and complications associated with them, which is why everyone is trying to figure out a better way. Perhaps you have heard of ADD? I will give you a clue it does not mean attention deficit disorder.

    3:18 Zimmer is sitting on about 2 billion in cash, how much cash are you sitting on? I guess the jokes on you!

    Instead of trashing the doctors, competitive companies and products, how about stating a position and backing it up with something other than... POD's suck, Zimmer sucks, Stuart sucks, Isp sucks. Are these posts all by the same disgruntled ex spine rep or what. At least make me laugh like 3:18 who after trashing Zimmer proceeded to let us all know Stryker and Orthofix are about to set the world on fire. After all these are two of the preeminent spine companies known for their ability to acquire spine companies and innovate spine technologies. Don't get me wrong I respect both companies but would put them squarely in Zimmer's league in terms of market share, breadth of products and way behind in their ability to acquire other companies. If you know anything about this industry you probably know that Stryker is very divisionalized and plays in many markets outside of spine and Orthofix is in debt. Stryker will undoubtedly make some acquisitions although I wouldn't expect them to lead the acquisition charge because there are a lot of division president's outside of spine and joints all pushing for their acquisition targets, they are a conservative company and they have already spent 300 million on Orthovita. Orthofix will be acquired in the next 12 months (probably 6).

    Love,
    2:16
    Class dissmissed

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  38. As long as the surgeon uses a fusion ISP with a good interbody cage, and supplemental bone graft posterolaterally, the results will be good. If he relies on grafting within the device alone, that won't be sufficient. Like any other device in the industry, it will work well when used properly in the right patient. In other words, if the surgeon treats the case like a proper fusion, the results will be like a fusion. If the surgeon forgets his fusion principals with these devices, outcomes will suffer.

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  39. Spine surgeons suck. Can we start a program at Stryker to make reps the whole shebang? Surgeon and implant provider? I think reps that went to junior college should run the whole market, personally I have played multiple hours of operation and have dominated my 12 year old cousins. I could be the next Randy Puno.

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  40. Interesting thread of comments...and as a surgeon who has used Aspen, NuVasive ILIF, X-Stop, Globus SP-Fix, as well as Globus Retain let me say the devices do work, and yes the right patient must be chosen. I'm surprised nobody referenced NuVasive's biomechanical studies, as well as those of Spire Plates which are as good as pedicle screws in flexion resistance. Thus if you have a good interbody construct, you can get excellent posterior stabilty with minimal blood loss as well as rapid insertion with these devices. Globus has the best instrumentation by far as well as an option for either the clamp alone, or the clamp with a spacer. They are soon to release a smaller implant that will fit better than anything else on the market to this point.

    Having taken out different implants (some of my own, as well as from others), let me assure you that they can and do fuse...to the point you must chisel out the lamina to remove the thing. Do they all fuse? NO. Do all pedicle screw cases fuse? NO.

    Now the thing we need is good information as to when to use them and when to avoid them. As a back-up to an interbody or TLIF they are superb to use. Also for 1 and some 2 level stenosis patients (but best used in conjunction with decompression). In my opinion use of bone allows for better fusion than using DBM, Actifuse, etc.

    In fairness, one doesn't burn any bridges with these and the intersting thing to consider is placing one of these devices at the top of a fusion construct to see if adjacent level collapse can be minimized...

    If everything about pedicle screws or facet screws was perfect we'd have stopped a long time ago.

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  41. 5:55

    Let me call class back into session for a moment:

    You say Zimmer has $2 Billion in cash? Really? That's great because apparently they know how to invest it about as well as Lehman Bros. & AIG,,

    Did Zimmer buy Endius? How'd that work out for them?

    How about their acquisition of Abbott? ANOTHER tremendous decision w/ stellar execution by Zimmer.

    Who cares if they have $50B,, it's very well documented that they are clueless when it comes to knowing how to properly invest it when it comes to spine.

    So seriously, get some facts before you spout off again w/ your nonsense.

    I believe the joke is actually on YOU my friend.

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  42. Right the first time, that is rich. Which one of your surgeons did you borrow that line from. You mean right 75% percent of the time for a one level lumbar with a 40-50% chance of needing an adjacent level fused in under ten years. Sign me up I want it right too, I think I would love to be a career back patient as well.

    I also love standing in three hour cases and losing a liter of blood, needing a transfusion, getting hooked on pain meds, staying in hospitals for a week at a time and being out of work for months. What's not to love? Perhaps your surgeons do mis, where the complications include the k-wire puncturing your bowels or aorta and greater chance of pedicle screw misplacement. You know what pedicle screw misplacement is, right? Laterally is no big deal although the construct will fail prematurely but that patient is already probably going to need a revision in the future for that adjacent level that you now have to fuse. Medially is not so good. I don't have any white papers but I don't think you have those kinds of complications from doing it wrong the first time with an ISP.

    Actually, fusions are great. Keep selling your pedicle screws and peek spacers and I hope you and your surgeon customer never get out of your comfort zone and learn or consider another option.

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  43. What about if one utilized an allograft spacer to distract the adjacent spinous processes and then backed it up with bi-lateral facet-pedicular screws (something similar to PERPOS or FacetFuse)?

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  44. 6;08 Actually it is very common for companies that acquire other companies to underperform post acquisition. In fact, (class back in session) it is very rare for companies to perform well after acquisitions, which to me is why Stuart has done a very good job at Integra. There are several instances of companies blowing up acquisitions in spine, such as Biomet/EBI/Cross, Medtronic/Kyphon, Stryker/Surgical Dynamics/US Surgical, Orthofix/Blackstone. Perhaps you could illuminate me on some of the glowing successes as your companies certainly have had their share of failures. Don't worry about it, perhaps your first position of Zimmer sucks and Stryker and Orthofix are the best is a far more compelling position for you. It is certainly backed up by fact. What is your position going to be when Stryker fires you and your Orthofix boyfriend breaks up with you? Don't trash the competition with your extensive knowledge of the power brokers in the industry you may be working for them one day.

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  45. 6:41

    Now I'm laughing up a storm,,

    For starters, unlike you who is CLEARLY drinking some sort of piss enhanced Kool-Aid, I do not work for any of the companies that you've mentioned. Therefore Stryker will not be firing me, nor will I find myself employed by Orthofix any time soon,,

    I'm sorry for your luck as you've clearly been dealt a bad hand having to rep for Zimmer,, but hey, attitude is paramount, and at least you have that going for you.

    As for my comments, take them as you may, but they are simply my opinions based on years of observation following this industry.

    Regarding your comments about Integra, let's see how things play out as the Thekken acquisition has produced mediocre results at best. As far as the SeaSpine peice,, only time will tell. The best thng that your boy Stu has going for him is that he has a very solid gent in place in Brian Larkin who should help get things moving in the right direction as it relates to spine.

    As for your last comment,, Perhaps you should ask yourself if maybe, just maybe,, I AM a power broker in this industry and how it might feel to find yourself working for ME one day??

    Karma can be a bitch my friend.

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  46. Which class was it in med school that taught you the spinous process was to be load bearing?

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  47. Dear 2:16/ 5:55,
    You can take off your scrubs now.
    You're a better fit posting on:  
    http://spineblogger.blogspot.com/2010/11/dont-take-me-alive.html

    6:03 Interesting points, but the "right patient must be chosen" = subjective.
    http://thejns.org/doi/pdf/10.3171/2010.3.FOCUS1047

    Kisses,
    Just a Blog

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  48. 6:37 - I've seen a surgeon use the Spinefrontier device with TruFuse. He thought the three points of fixation would make for a more stable construct. Does anyone else see this?

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  49. 7:06

    The interbody cage resists flexion. The interspinous clamp resists extension. They work well together. Perhaps if you went to medical school you would be able to comprehend these sorts of things.

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  50. 8:01 - please read my post again. And then read yours. Yes, that's right, the interspinous clamp generates load on the spinous processes during extension. So, I'll ask again: which class was it in med school that taught you the spinous process was to be load bearing?

    But, thank you for clearing one thing up: they did not cover this in community college.

    -7:06pm

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  51. Medtronic also sells a Z shaped spire plate

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  52. 706

    Yes the spinous process is designed to take loads in extension. What do you think the interspinous ligament does? It limits extension through the process- and with a longer lever arm than an interspinous. Read Panjabi and White - it's stronger than you think. An ISP placed properly (as anterior as possible) actually places relatively little load on the process and more on the lamina and middle column.

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  53. If your a power broker the talent at the management level in spine never ceases to amaze me. Undoubtedly you have heard of the Peter Principle? I don't work for companies I distribute them so I don't know how that karma thing is going to work out for you. What are you a regional sales manager (excuse me Vice President) for Trans1 or something? Now that is a thread, "The exceptional regional sales managers of spine!" Or why all the RSMs got new VP titles. Let's call them RSS's, Regional Sales Secretaries. Isn't it funny that you don't hear from your RSS all month till the last day of the month when they call to remind you to get your pos in or ask how much you have out standing so they can cover their ASS.

    I think it was the same class that taught transverse processes should be load bearing in posterior-lateral fusions and how similar the biomechanics of a fused spine and virgin spine are. If you have a problem with the sp load bearing put in a interbody device and you have a construct that is every bit as strong as screws and interbody not that anyone can prove that is a good thing. That way you save us all the time and x-ray exposure from putting in screws.

    I will post where ever I see people make idiotic statements about surgeons, companies and products. A lot of surgeons read this blog and I hope all the surgeons that use ISPs (fastest growing market in spine-well over 100 million in us sales) don't think all the reps in the industry are as poorly informed. Why dog the competition? They are all doing somethings right and somethings wrong. I don't work for Zimmer, I am a distributor for several spine lines but I have worked or represented Zimmer, Stryker and Blackstone and I think they are all good companies and none of them great. Which goes for most of the industry. I am certainly not concerned with competing against Medtronic, Depuy, Synthes, Stryker, Zimmer, Nuvasive and Globus.

    I am also partial to the wearing scrubs club. It is easier to get in and out of hospitals, differentiates you from the pharma club, hospitals in my territory don't give out scrubs and it makes it easier to manage my ever expanding waistline and distributorship.

    Again make/take a position and back it up. The sucks position or you should post there is like preschool. No, you suck and you post there. How does that sound? Back up your position with a persuasive argument and I am far less likely to counter the other side! Don't be afraid of ISPs, Zimmer or anyone else. In my opinion it is the people who bring value to the industry and not the products, companies and models. What value do you bring if all you do is put down technologies, companies, products and people?

    The finger,
    Just a Blog :) PS Bringing up blogs from 2010, that is sad.

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  54. As a rep who has supported a handful of ISP cases, I am curious about the suggestion by 6:03, surgeon, that all ISP's should be done in conjunction with an interbody spacer. My impression is that ISP's offer stability/fusion(?) while leaving the anterior column intact. Wouldn't this be preferable if the disc is in good shape? In other words, used to mitigate stenosis...? Aren’t ISP’s purportedly a “conservative” approach prior pedicle screws and interbody fusion?
    Additionally, how about a little more constructive conversation on patient selection and proper indications for use? The back and forth between whiny reps is exhausting. Don't you guys like to get into the clinical discussion? Isn’t that why you read this blog?
    Just looking for some legitimate feedback here.....thanks.

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  55. 157

    I think you need to see the distinction between fusion ISPs like Aspen or Axle and nonfusion ISPs like X stop or Coflex. They are apples and oranges even though people tend to lump them all together. With the nonfusion devices, the goal is to preserve anatomy and the anterior column. These devices are designed to preserve motion and therefore NEED to have an intact disk.

    Fusion ISPs are supposed to arrest motion. A fusion is a fusion and there should be no more motion in an ISP fusion than a pedicle screw fusion, once a bony union has occurred. Therefore in these devices, preserving disk anatomy is uneccesary and even undesirable. A cage will help to stabilise the fusion just like with pedicle screws.

    So the key is to determine the intent of the surgery- motion with preservation of anatomy or fusion with altering anatomy. There are pros and cons to each. Unfortunately the line has been blurred by a few unscrupulous surgeons who bill the nonfusion devices as fusion to get a higher reimbursement. This has created a lot of confusion, even with experienced reps.

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  56. At some point, hopefully, some of you will come to the realization that the spine is the most complicated anatomical structure in the human body. And, as a result, there are no single solutions to addressing spine maladies and pain. There are times when pedicle screws are the right option, when the spine is so unstable the only answer is lots of steel. But there are others when less is more.

    One of the biggest mistakes I have seen by surgeons and manufactures is assuming one device or one technique is the best for all maladies. Before bashing a device or technique, take down your concrete wall and give consideration to a new or different idea. And give consideration to alternatives to the status quo.

    The spine industry has been stuck in a considerable rut for way too many years. Consider how many times MM has asked about what's going on in new technologies, and what do we see? New polish on an old idea. Hell, even ISP devices are not new. It comes from work Bowman did probably 30 years ago, but biomechanics and materials where not invented yet to allow them to work opitimally.

    Having been a part of or having studied biomechanical research on just about every spine fusion or stabilization invented, to include ISP devices, most would be surprised at how well many of the ISP devices compare to pedicle screws.

    My point, don't "down" it until you know better. Have some respect for change and innovation. Spine is in a rut, a deep one. Innovation has taken a back seat to copy cat technologies due to the ease of market entry, and the ability to make a few million bucks by doing a couple of deals with key surgeons vs. doing something different - that will make a difference.

    Is ISP the answer to all spine issues? Hell no, just like pedicle screws, dynamic stabilization , stand alone devices and TDR are not the answer for all things. For you nay sayers, get a clue and do some research before spewwing your closed minded junk.

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  57. Ole dad said "the spine is the most complicated anatomical structure in the human body"

    Interesting point, but us poor country brain surgeons would kindly disagree!

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  58. Would you invest your $ in one of the non-fusion ISP products going through the PMA process? It doesn't seem like there is a market for that based on the low barrier to entry into the fusion ISP market and surgeons can bill those as a fusion. Wallis, Coflex, DIAM...these products are dead on arrival, and doubt they will ever arrive.

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  59. The whole discussion about the forces on the spinous process is pretty funny. The interspinous ligament is there to avoid the spinous processes from separating too far when the whole spine is in FLEXION. At that time the ligament stretches and PULLS on each of the processes, there's no compressive load. If the whole spine is in EXTENSION the spinous processes are now contacting the ISP device, and experience a vertical compressive load they were not designed for, which is evident from their shape. So, if the processes don't fracture, Wolf's law (there it is again...) will cause the spinous processes to remodel around the implant and any benefits derived from the segmental flexion forced by the ISP, which is intended to prevent the canal from narrowing at that point, is lost. ISPs are relatively successful because they are yet another income creating step in the continuum of spine care, from IDET (sic!) through discectomy to 12-level fusion.

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  60. 5:09 Good point. And, should have qualified. Have alway considered the brain an organ, and the spine a more bio-mechanical structural/organ system.

    5:36, Coflex will arrive, Wallis works well, but too much work (also too hard to get throught the FDA in current form) and Diam is just not hardy enough to be real effective. But, the question is would I invest. Not in the current devices, but might of some that are being worked on that control motion but not so much it affects adjacent levels.

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  61. 4:37, appreciate your thoughtful response to the earlier email. It seems ISPs would also be useful to stabilize posteriorly following a lum/lam. In those cases, motion sparing device would not be desirable, IMHO. Would love to hear some debate on this concept.

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  62. anyone heard of these guys? Is this a Nuvasive killer?

    www.innovativesurgery.com

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  63. What about Co-Fuse, the Co-Flex with a bolt? Hows that one working out?

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  64. Co-Fuse is Paradigm admitting to being a $15M company instead of a $1B company.

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  65. Dear "The Finger":
    What the hell was that? Please refrain from posting while intoxicated.

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  66. Let's not forget, all the ISP's are just me too's of the X-Stop.

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  67. The only reason products like Aspen have been successful is surgeon coding...those devices perform the basic function of an xstop when patient is in extension..no one expects them to fuse in between the two spinous processes...How many mild to moderate stenosis patients are being fused today that should have received a laminectomy? Why is that do you suppose? The true ISP devices (xstop) are geared to provide an alternative to laminectomy and not burn any bridges clinically..regarding the posterior spine biomechanics, only 20% of the load of the spine transmits posteriorly and it acts as a tension band, not a loading environment. Therefore, sticking a 'fusion' ISP device in will not see the load environment like a cage and thus will more than likely never fuse...if surgeons got paid $1500 for putting in an xstop do you think the dynamics would change?

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  68. Did globus go public yet??

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  69. No, and nobody wants to buy them either.

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  70. "Now onto something more serious."
    WOW! Your going to love this one/ cringe.

    http://www.massdevice.com/news/fda-device-chief-shuren-recession-played-role-pushing-medical-device-industry-eu

    S.S.

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  71. Anonymous said...
    anyone heard of these guys? Is this a Nuvasive killer?

    www.innovativesurgery.com
    June 3, 2011 6:29 AM

    Dr. Bartol I assume? Shouldn't you be in surgery or something

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  72. Globus Rules and the Rest Suck..

    Like the Dr. Said...

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  73. Globus rules what.............the checkbook for surgeons? Buying the business doesn't mean one rules sh&t!

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  74. Paradigm's coflex seems to offer a wonderful transition from spacers. The clinical trials seem's to be extremly successfull, and lets face it this coflex is a evolving soulution to whats in today's market, also the x-stop has had great success. Bottom line, people will always be upset when other companies have success, my father has the coflex and for the first time in 6 years he is pain free. WE played golf for the first time in 7 years this year and i have my dad back thankyou vb.

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  75. sounds like an ad but your right its not a spacer.

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  76. Your dada might have played golf after a simple (partial) laminectomy as well, or even better. You can't judge a device on one uncontrolled case. Regarding the trials, I've seen the CoFlex informed consent documents for the European arm of the study. A friend was asked to participate and she sent me the information she had received. I.m.h.o these documents do not adequately inform the patient, and are biased in favor of device. It would be interesting if we could find out to what degree that influences the (perceived) outcomes as reported by the patients.

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  77. Anonymous said...

    "Dr. Bartol I assume? Shouldn't you be in surgery or something"

    That's funny.... but it's not Dr. Bartol.

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  78. Hey...Let's talk about POD's. It's been 78 post and no mention of POD's. I think we should talk about POD's now. It's the only interesting thing going on. POD's.

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  79. Pods suck. .... Just a joke

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  80. Endius has a very good product line. The question that "anonymous @5:55" should be asking is whether or not Zimmer knows how to capitalize on Endius' products. From what I saw of Zimmer's engineering staff and management, they are definitely not the sharpest tool in the shed...imho.

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  81. I have back pain

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  82. Has anyone had experince with the MILD system by Vertos Medical?

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  83. Zimmer's engineering staff and management definitely are not the sharpest tool in the shed but neither are the engineering staffs and management at Endius and Abbot. The medical device industries are led by dumb and dumber.

    It is the survival of the dumb (and not dumber).

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  84. I am currently researching your Aspen device

    I had the Lanx Aspen installed 8/1/2011 and late 2013 the pain started to return,after some imaging studies and an Discogram it was found the system had failed. 1/9/2014 I had surgery , they removed the Aspen system and installed the old fashioned rods and screws. Aspen tells surgeons it’s to be used on a multi-level hernia’s. I know, I called and asked their customer service. When I checked your FDA approval as well as researching your patent information I found it was approved for ONE level only! I have issued a plea that if anyone else (as I have read on the internet) has experienced as drastic failure. My fusions had not taken at any of the effected areas.

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  85. has anyone else had failure with spinal usa hardware . screws backing out and plates breaking

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