Monday, February 21, 2011

Grasping At Straws or Just Plain 'Ol Grasping?

On February 18th, 2011 the Big Z reported that it had introduced the spine industry's "FIRST" porous metal cervical device.  One must be amused at the hoopla and gyrations that some of these companies go through for a little bit of publicity, especially when it's really much ado about nothing.

As one of our blogger's stated in an e-mail to TSB, "SO WHAT?"  In all likelihood many industry analysts  may be mesmerized by the magical properties of trabecular metal that will make them believe that the Big Z is on to something big.  TM-S is the first cervical product that incorporates porous metal technology.  But the question must be asked, "have we had any difficulties in fusing the cervical spine with the current state of the art?" Hedrocel as industry veterans know it, has been around for many years.   If TSB's memory serves us correctly, in 2000 Zimmer originally licensed this material from a small company in Allendale, New Jersey known as Implex which was owned and operated by Alex Khowaylo.  In 2003 Zimmer acquired this material from Implex for common stock and a customary cash escrow with the intent of using this material in its hip and knee products.  Hedrocel is a biomaterial that approximates the appearance and porosity of cancellous bone forming a strong bond eliminating the potential for particulate wear debris, hence, Zimmer's original interest in this material.  In retrospect Alex probably laughed all the way to the bank, cashing out and getting rid of Robert Cohen (I believe that was his name), one totally wild and crazy guy. But what is even funnier about this press release is that Zimmer's new President, Steve Healey is quoted as saying, "With the introduction of the TM-S System,  Zimmer is bringing the potential benefits of porous metal technology to cervical interbody fusion."  In addition, "The osteoconductive properties of Trabecular Metal support initial fixation and can potentially aid in cervical fusion."  Let's be realistic, if trabecular metal can potentially aid in cervical fusion, how much better can it really get?  Can we take it from 94% success rate to 100%?  What happens if the patient has other associated medical conditions?  What happens if the patient is a substance abuser, or smoker?  What is the comparative modulus of elasticity of trabecular metal to PEEK?  Making blanket statements in press releases leaves much to the imagination, let alone the credibility of the person making the statements.  So TSB wants to know, is Zimmer blowing smoke at us, or do they really believe their own press clippings, you be the judge.

79 comments:

  1. Zimmer Spine has been marketing TM in the cervical spine under the "VBR approval" for years (I know because I was a ZS rep once upon a time). So now they have a "cervical interbody fusion" approval. Big deal. It costs too much and it does not improve outcomes. What's the point?

    Don't get me wrong...the folks at ZS are good people (at least they were when I was there...not sure who's still there). I left the company on good terms, and I wish them no ill-will. They just don't have a clue when it comes to new product development. Pathfinder NXT was supposed to have been "months away from being launched" when I left the company almost two years ago. I mean, it's not like they were developing some totally new earth-shattering technology. It's just another perc screw system. Looks and works very similar to NuVasive's perc system. Nice, but certainly not any different than what is already out there.

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  2. Doesn't anyone look at sale reports over there?

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  3. Can anyone say MRI or CT artifact with that fat hunk of osteoconductive metal? And what about the revision with said hunk of metal? Unlike PEEK or bone that is relatively easy to drill out should a non-union occur, can't imagine the revision with that in the C-Spine. Came over from joints about 7 years ago and surgeons were already casting a wary eye about having to revise a TM hip or knee. As TSB stated, much ado about nothing!

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  4. Coming up with a better titanium interbody is like coming up with a better buggywhip.

    Sad days for the circle Z indeed.

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  5. The merits of TM aside, I think reducing a failure rate from 6% to something less is a commendable goal, and I'm pretty sure the 6% of patients who don't fuse would agree. That said, I agree Zimmer should go suck it.

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  6. TM in the cervical spine. Does it work? I does, and does so quite well. To include smokers, to include diabetics. Does bone growth through it, x-rays I have see say no, but does on the surface. Is it better than PEEK. Better is a relative term. PEEK does not allow ingrowth into it any where. That's an issue with diabetics and smokers, and those at high risk fusion patients. With TM, it doesn't have to. And though there was no mention of the mechanical characteristics, but the information is out there and I'm sure Z will make sure it's known.

    Question is, is it X% better such that the price justifies a premium price. Is it 6% better, 10% better ... who knows at this time. Is the requirement a slight change in technique enough to justify the price? It's a bit of a stretch. If Z's approach is to deal with the problem patients, and get pull-through with the other products like plates, that's a pretty risky strategy. But considering Pathfinder NXT is the first thing they have introduced since the acquisition, and it's a product improvement, introducing anything new gives them something at least positive to talk about.

    The thing is, is it too little to move the needle, or too little to late. If I were a betting man, and Zimmer Spine was a stand alone, I wouldn't put a nickel into it. There are still to many questions about them in general. With the recent layoffs, and what appears to be more to come, what is to become of them?

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  7. They should spend their time and money acquiring a decent biologic. They are struggling in that area.

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  8. Imaging Problems? CT Myelogram is the answer.
    Patients love them.

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  9. Zimmer Spine's incompetence with the Dynesys IDE is all the evidence you need to show Zimmer Corporate and Zimmer Spine are full of rank amateurs at best. They had a chance and blew it. Since then they been losing market share and, more importantly, quality people. Honestly, who is "recruiting" Z Spine corporate sales folks away ... anyone? I see marketing and non-corporate "field" folks in positions of influence in other organizations but I haven't seen a Z Spine corporate RM, AVP, DM, etc ANYWHERE else. I wonder why that is? I mean are they "rewarded" for losing that much market share?

    The quality people stay for 12-24 months, figure out the futility, and get the f out. That leaves the C and D players in positions of influence.

    Metal as an interbody option in ACDFs? Good grief they've been pushing that for almost 10 years but NOW they can show images. What's next? Re-Package and launch BAK III?

    Warsaw has never understood the Spine marketplace. Seriously, NASS was just a few months ago and they could have announced a new perc screw then. Hell even Dvorak said in the first analyst call of 2010 that that perc screw system would lead to increasing sales in Q4 2010. I'm willing to wager that isn't the first time that perc screw product launch was pushed back.

    Anyway, I'm sure the 15 spine surgeons in the exhibit hall were impressed.

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  10. The issue with Z's TM product is that it still requires an anterior plate. That is the problem with the construct, and any material that requires and anterior plate. As TSB states there is a high fusion rate with ACDF, so how do we improve ACDF? You need to focus on the problems and fix the problems. The areas that are problematic with ACDF are the following:

    Adjacent Sedment Disease (ASD)- 26% at 10 yrs over 2 1/2% per year - (Hillibrand et al)

    Adjacent Level Ossification Disease- 46% with ACDF (Riew et al)

    When you use a plate, it must be >5mm from the adjacent disk space or it will result in (ALOD) nearly in half of all patients.

    When you do a one level, it is easy to meet this window of safety. However, with a multi-level plate it is more difficult because it has a static design and non variable geometry in 2mm increment heights. However, since the average cervical fusion involves 1.7 levels this challenge is very prevalent and the ability to keep the top and bottom of the plate at least 5mm is more difficult.

    Disk specific implants are the answer.

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  11. Titan and Amedica do the same thing, only better.

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  12. Titan Spine's "acid etched" implants are crap! Sure they have a high coefficient of friction, but at the end of the day, they are still made of TITANIUM! There's a reason docs stopped using solid titanium interbody cages years ago...the modulus of elasticity is way too stiff. I rest my case.

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  13. The problem isn't with the interbody material it's with the tension band. The biggest issue at CSRS this year was adjacent segment disease (ASD) not only because of load transfer, but also because of the damage that the plate causes during and after placement, including loss of vertebral vascularity, ligament damage, plate impingement leading to ASD, ossification of the disk among other issues.

    Doesn't anyone listen to the papers presented at spine meetings? CSRS did a whole afternoon instructional workshop on the issue. One of the most quoted cervical papers in spine is Hillibrand's ASD paper.

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  14. Cohen....hahahahahahahaha. How long did he last as president of Zimmer Spine? 6 months? less?

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  15. To address concerns by 11:20 about revisions, my past life was in orthopedics and I was in the OR for numorous TM tibial revisions. The last cervical IB I would want in me would be one made of TM due to the debris generated during removal. Nothing like thousands of small metalic particles roaming around in the spine. However, it might not be a bad option for patients at high risk of not achieving fusion with PEEK or bone.

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  16. @ 7:39

    Very good point. Designers in spine always forget about revisions. Deep bony ingrowth through the implant is nice, until you have to do a two-level corpectomy to get the thing out.

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  17. Dear idiots
    If you have a fusion the chances/reasons for you doing a revision are minimal... duh

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  18. 2:34 - Very well put. Next time don't beat around the bush - say what's on your mind and get to the point.

    Today is national margarita day - Mas Tequila!

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  19. This comment has been removed by the author.

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  20. 2:59PM Finally someone with some sense!!

    The Perfect Margarita
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    1 1/2 oz. Cointreau or Patron Citronge
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    Salt for the rim of the glass
    Serve up

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  21. Who is 3D Spinal Solutions out of Scottsdale?

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  22. 3:48
    I'm pretty sure it's Keyser Söze.

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  23. Steve Healey, formerly of disc dynamics? The wheel goes round and round.

    In any event I don't think many CEOs believe their press releases.

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  24. Hey 2:34, sorry, but you're the idiot. You may only have fusion (ingrowth) on one side, which may necessitate revision. Also you may have an inadequate decompression or recurrent nerve compression which may necessitate removal. Bottom line is that previously placed grafts are drilled out again with some frequency, and it's foolish to think it won't occasionally (and perhaps even more frequently) need to be done with TM.

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  25. Synthes is stagnant; Stryker has peeked; Depuy is a sinking ship; Zimmer is the only one poised for major growth. Big Blue Z will rise like Phoenix this year.

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  26. Of all the issues with trabecular metal, the most problematic is difficulty in assessing fusion status. Not a problem if patient is doing well, but what how do you handle a patient who is not doing well clinically? The first question in this algorithm is fusion status.

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  28. Zimmer has spine?

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  29. Sure.......Zimmer has spine

    Their stuff is older than my grandma's wooden tampon

    about as useful too

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  30. Gasping is a better term.

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  31. 3:48 PM

    3D is darrell denslow. He is the new alphatec distributor in phoenix. Pretty shady character.

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    Replies
    1. Shady character? Darrell Denslow is the epitome of professionalism and class. You sir are incorrect. You should be careful of the slanderous things you say.

      Delete
    2. He lies about having a Masters. Who does that???

      Delete
    3. Darrell Denslow actually has a Masters in Business Administration (MBA) so once again, incorrect.

      Delete
    4. Darrell Denslow is in fact one shady character. His MBA is from an online college and his claims of success are for mediocre spine companies who pay for their business. He's a scum bag with drug problems.

      Delete
    5. I heard 3D Spinal ( Darrell Denslow ) has a alcohol, cocaine and more addiction, tried to commit suicide and is losing everything. Sounds like a scum bag with problems.

      Delete
    6. The posts are hilarious. Zero fact and all talk about people that want to take a champion down. I know Darrell and he is a upstanding business man and philanthropist. He has donated more in a year than these bums have made in their career. Stick to truth people and the slander is only from the haters that watch his business grow and sit on the sideline unable to get in the game.

      Delete
    7. Darrell Denslow is a complete and total fraud. If his mouth is moving it's because he's lying, cheating, stealing or he sucking something. Darrell go ahead and post that this is untrue and I will post the proof. Stay as far away from this man and his "family" as possible. Go ahead and spend some time on The Arizona Maricopa County superior court case lookup website. Quite an eye opener.

      Delete
    8. Yes! Superman is not so super. Darrell Denslow has quite a history on Maricopa county website. When will people finally figure this disturbed man out?! Good talker but in the end is just a piece of trash. survives off lie's and being dishonest. Wake up people!!! This man is a fake.

      Delete
    9. I have known this man for many years. My wife and I were close friends with him and his ex-wife, DeLinda. Unfortunately, if his lips are moving, he is likely lying. I counted seven lies just looking at his linked in profile when he added me as a contact. It's very sad, but karma will handle it.

      Delete
    10. http://kathryndenslow.blogspot.com/search?updated-min=2014-01-01T00:00:00-08:00&updated-max=2015-01-01T00:00:00-08:00&max-results=1

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    11. How many ex-wives are there? How many times has he changed companies? Now he is out of spine? Sounds like the karma train is running full speed. Hope the strippers at least still have his gifts to show for it all.

      Delete
    12. Ask Dr.Chris Meredith in Kansas City about this guy. Run at the sight of his fake teeth!!!!

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  32. TSB, love the blog and read it frequently. Though this is only my 2nd ever post. Usually don't disagree or don't know enough to comment with certainty. On this one however, I do...
    I'm a ZS guy and not here to argue the merits of ZS well-documented revolving door with senior mgmt, many mis-steps, poor product pipeline,etc. Also not here to argue whether or not TM is the best product for cervical fusion, or whether fusion rates can be improved, that's for the customer to decide. But the material is unique and has properties that are clinically documented in 100's of peer-reviewed articles and prospective studies. It has modulus of elasticity similar to cancellous bone, strength of metal, doesn't migrate and bone grows into and around it rapidly. You dopes that say it's old or is just like Amedica can't be convinced because you already know everything.
    If being "old" was a problem we wouldn't be selling pedicle screws. My surgeons can easily understand how to assess fusion with imaging which is only a customer objection, not a problem. I'll keep making money on the product and supporting my surgeons who get great results with the product while you guys point out what's wrong with it and ZS.
    Finally, It's a press release geniuses. Marketing 101 dictates that Healy's not going to say "We got an approval for a product we've been selling for 5 years and we want to publicize it and act like it's transformational". What the hell do you expect him to say???

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  33. "can potentially aid in cervical fusion?" As TSB stated have we had real issues with cervical fusion? You're obviously correct that its marketing 101, but you're looking at it as another product that you can attempt to sell, and justify the increase in cost. Don't sell this to your friends, go and make cold calls and try to sell it on its merits and then see the clinician reaction. Do you honestly believe that you are going to flip the Danek Surgeon with this product? The Globus surgeon? The Synthes surgeon? As for your new president's comments maybe he needs a publicist or some clinical experience instead of feeding the marketplace anecdotal non-sense.

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  34. Ignorance is bliss huh? We're converting competitive surgeons and the documented, clinical findings of this material are clear and demonstrate superiority. It's up to me to convince surgeons that it will help them, their patients and is a better interbody, and I do. Remember, we're ZS, we have little market share and few friends, nearly EVERYONE we convert is a competitive surgeon. I see each day how folks in this blog try to put down every other product and company, go ahead.
    As for Healy's comments, they are solidly fact based and provable. Read the articles. Keep in mind that he is limited by the FDA in what claims he can make. BUT, the information is certainly not anecdotal.
    By the way, my office day today is quite productive and fun because I get to joust with folks like you...

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  35. Hey 7:19 How do you have the same Modulus of Elasticity as cancellous bone yet the strength of metal? So does it crush like cancellous bone, or does it plow like metal? Which is it? If that is the sales pitch you go with I am not sure you really have any business at all!

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  36. You really don't understand how you can have both? READ... It doesn't have to be cancellous bone to have the same spongy characteristics. You might want to start by understanding what modulus of elasticity means.
    Do you understand how a big boat can float on water when it's very heavy? READ...
    Surgeons understand because it is a scientific fact. Obviously they don't all use but you can't refute the science, or maybe "you" can.

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  37. TM worked GREAT in cementless hips and knees.

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  38. Hey 7:19 it's morning on the left coast and I was wondering if you live on the other side of the country are you working or are you lining up all those cervical cases that you'll be getting with TM, LOL....................as TSB once said, suicide is painless, bring back Schlotterback at least he was a decent guy, and get rid your business development guy and you may have a chance of coming back from the dead, one day.

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  39. My family and I are thankful that we have a large number of sheep surgeons that follow us blindly and don't read or think for themselves rather than all you mensa society members that know a lot.

    BTW, 3 cases going as we speak. I have a number of good reps that don't seem to have a clue. They go out and sell and don't pay much attention to all the smart folks that are happy to explain to them why they can't.

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  40. While TM is probably a crummy choice anywhere in the spine (Imaging is terrible)....

    Steve Healy is a solid guy.

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  41. Hey 7:19 it's much much easier to just pay the surgeon, what the hell are you thinking???? you will only get 1/10,000 to use your stuff if you are trying to make rational claims of outcomes and efficacy! tell um you got $10,000 american greenbacks and now you're talkin!!

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  42. That would be way too easy. We like the tougher route, remember we're in Spine and work for Zimmer!

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  43. Next Up,

    Gender Cervical Plate,
    A Female Cervical Plate and cage in one.
    With spring loaded action for easy bobbing.

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  44. Don't work for Zimmer Spine, but I did. And can tell you, TM was fun to sell. It is differentiating. And it worked, especically for the problem patient. And like many who have commented negatively, your assuming, like most surgeons at first glance, that this is a solid hunk of stuff and titanium in the spine is past it's prime. Well, it is past it's prime in solid form. Like the ZS guy above, this is not your grandma's titanium. Most know bone likes to stick to Ti. That's a good thing. Also most know bone DOES NOT stick to PEEK, that's not a good thing and why it is not used without ventral column support of some form unless the implant is hugely wide and deep or it spits out (pretty common in Europe where they won't pay for the extra cost of a plate). As far as revisable, been there and it's surprisingly easy and safe for the well informed. No, it does not have to be drilled out. Truly the only snag I had was cost.

    As far as Zimmer Corp goes, it's an absolute shame that so much time and energy has been waisted by so many creative, hard working folks who gave it a go at Zimmer Spine and became so frustrated they are willing to do anything else to not work there. The culture there is one of survival and CYO. With the brand name they have, it should be going gang busters. But then attornies are all about protection, not progression.

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  45. @7:23 You make good points. But, like I said earlier... why use TM when SiN does the same thing only better... not to mention it has incredible imaging qualities.

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  46. 2:24PM, Trabecular Metal is made of TANTALUM...not titanium. I have a hard time believing that you ever had any success selling it if you don't even know the most basic facts about it.

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  47. Maybe thats why he had so much fun selling it when you are selling titanium rather than tantalum LOL hahahahahahahahahahahahahaha

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  48. Could be worse. You could work for Medtronic and be facing layoffs.

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  49. There is a great post on the yahoo message board titled "Morale" from Dec 2010. Just another illustration of the culture of mistrust that permeates that organization.

    The Spine CFO/business subtraction expert along with a former interim VP of Sales and his Austin fraternity brothers completely alienated the field and corporate peers. Nobody trusts anybody. That organization is terminally sick and can no longer attract and retain talented people (especially in the field).

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  50. And if you want to remove it after fusion, do you do a semi corpectomy?

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  51. @ 2:15a.m. hey Griswald.. how do you remove a PEEK cage after fusion? with a magic wand? after a true bridgeing boney fusion? well, you remove TM the same way. By the way... how often do your surgeons remove cages after Fusion? Did they send you that line on a competitive sales brochure from your marketing department? Keep selling the way your Marketing Department instructs you too. Better make sure you keep your consultants signed on. You do not present well.

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  52. @5.07am Seems like I struck a nerve. If you are right, then PEEK will die a slow death in cages? Wake up, smell the coffee. TM will never take off... maybe at your best mate's account, but you are not going to take away business from a PEEK user.

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  53. Globus introduced a hybrid expandable PLIF cage at AAOS in San Diego and is heavily advertising it on the Spine Journal.

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  54. @ 5:40 you did not strike a nerve. Having TM and PEEK in my bag as well as bone, gives me options. I sell enough of all three.
    I simply asked you to present to the Spine Blogger readers a rational explanation of your post. You asked how do you remove a fused TM device? I asked you to differentiate removing a Fused PEEK device from a TM device. You cannot explain because you don't know. You should not post online until you have something to offer and you have some experience, What you will learn is that options are good, and surgeons like options. TM, PEEK, allograft.

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  55. has anyone ever heard of infuse?

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  56. Infuse = what my wife does to sexual advances....or is that refuse????

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  57. Here this sums it up....

    http://www.zimmer.com/z/ctl/op/global/action/1/id/9193/template/PC/prcat/P6/prod/y

    Some unique characteristics that give a surgeon options....isnt that the key to sales success....giving a surgeon quality service and options to practice the art of medicine??

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  58. WRT Medtronic lay-offs:

    Word is, firings will continue until morale improves....

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  59. Has the U.S. spinal procedure volume slowed down over the last two months more than the normal down turn during Jan. and Feb.? If so, why

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  60. All of this bagging on Zimmer and Globus and you have failed to ever mention the complete JOKE of a management team at Arteriocyte! These guys and gals are flat out the WORST. I've heard HORROR stories from distributorships and employees. How long before this group is brought in front of some sort of venting by TSB?

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  61. Arteriocyte is sorry and the FDA letters confirm it. However they are an insignificant non factor with sales less than your corner 7-11.

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  62. Has anyone heard about the Globus interbody material that remodels into bone over time. Heard of an IDE study the other day that they are conducting.

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  63. How many times in the two last years have the Finance guys at Abbott corporate shared a laugh over unloading Abbott Spine to Zimmer?

    In my opinion that was close to a mortal blow to Zimmer Spine. I'm not sure they will ever recover from that horrible decision.

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