Wednesday, August 24, 2011

DTRAX: Will It Make a Difference?

The word Providence is defined as a manifestation of divine care, hopefully Providence Medical Technologies will direct their universe and the affairs of spine patients in the future with wise benevolence. Some of you are wondering who is PMT, not to be mistaken for DMT, and what is it that they are hawking?

PMT is a privately held company developing percutaneous spinal therapies.  If you are interested in learning more please log onto http://www.providencemt.com.  No TSB does not have any vested interest in this product, nor do we know any of these individuals personally. What Providence has is a facet system called the DTRAX, no relation to every salesman's nemesis, REPTRAX.  The DTRAX is a facet system for the cervical spine patients with radiculopathy.  The premise is to decompress and stabilize the affected cervical level via a minimally invasive approach.

The powers to be at Providence are Art Taylor and Jeff Smith  formerly of Kyphon fame who have aligned themselves with an Advisory Board comprised of Drs. Berven, Bradford, Eyster and Harvinder Sandhu.  Considering some of the previous technologies that have been marketing for facet therapies, maybe these guys are on to something, but you know what TSB says, can this technology stand up to the test of time?  Only time will tell. TSB wants to know, what our readers think?

238 comments:

  1. From my understanding, South Carolina Spine Society had a closed door meeting and a statewide POD was voted on.

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  2. Good advisory board, interesting concept. Questions:

    1. What biomechanical testing has been done, and what are the results? I doubt that this construct immobilizes sufficiently to allow bone to heal.
    2. You create segmental kyphosis, which needs to be compensated. Increased risk of further degeneration? How many levels could you do before you stare at our toes?
    3. On one of the videos the core screw or delivery tool appeared to get pretty far anterior. Risk to vertebral artery?
    4. Surface preparation on the outside of the facet seem flimsy, and any cartilage removal inside the facet itself is minimal, if any at all. So, surface available for bony union may not be enough. (CT video does not show a convincingly healed segment)
    5. Bone graft used on the one videos was radiologically invisible, if that is what was done during the poking around. What is it and why would it stay there?
    6. Patients shown obviously were done in some central or south american country. For overall credibility starting in for example Europe would have been preferable.

    Again, interesting, but with the limited data available the jury is definitely still out.

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  3. 7:51 Please explain in a little more detail. For what its worth, their annual meeting isn't until September.

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  4. Check out the proven facet screw technology. www.spinefrontier.com

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  5. Isn't there concern of excess radiation exposure per the in-theatre video?

    P.S. All other facet screws are already proven helix geometry. The word “Technology” is more often overrated in the spine industry.

    P.S.S. TSB Rules!!!

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  6. I saw a poster by Berven for this product at IMAST. Pretty interesting and concept makes sense. Lordosis data for 1 level looked okay, > 2 degrees at treated level. Not sure about multiple levels.

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  7. I like it! I could sell that system...

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  8. I'm not sure the world really needs another cervical device. The 1cm incision is nice, I suppose.

    But I'm in engineering, not Sales. Here's my 2 cents:

    From a mechanical standpoint, if that implant ever comes loose, and it will for some portion of patients, that could be a big problem. It looks like it has a lot of sharp edges.

    Second, the bone graft material is another weak point IMHO. It could (and will) break away, or pieces of it could break away, that's not good, esp. if it finds its way to the foramen. Now you have a whole new iatrogenic problem when it starts pressing on the nerve.

    I wouldn't invest in this thing, but if I was smart I'd be rich. Which I ain't.

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  9. Becky, stop promoting. That frontier screw is absolutely uninteresting, and not even intended to fulfill the same purpose as dtrax. Dtrax is a nice concept, but as yet without proof.

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  10. These guys are nuts. What's the point of developing a novel device. If they were smart they would have developed an anterior plate with some magical new design. Maybe even the 20th cervical disc. Better yet, a kyphoplasty system. You with me?

    I mean seriously, what's the sense in attempting innovation. Spine needs more me too's to help accelerate pricing erosion and commoditization of hardware.

    Then we'll be able to get rid of reps (and their 15-20% gratuities) and make Obamacare really work.

    Keep those anterior plates and pedicle screw systems coming. I say down with DTRAX and other devices of its kind.

    Product differentiation like this will only preserve profit margins and validate the need for case coverage reps.

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  11. Would like some advice from any of you readers of TSB. Does anyone know for sure the name(s) of California hospitals using AlphaTec spine equipment? I'm interested ONLY for personal reasons. I am not a rep or a competition in your field. Pretty Please!

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  12. I think 10:20 hits the nail on the head or neck. I'd rather see something in a solid PEEK form that replicated the same effect without the sharp edges and potential for bone graft migration. I do like the mini posterior approach conceptually if you could make it safe and effective. Less morbidity treating the radiculopathy but what if you do have to go back and revise due to the fragmentation of the bone graft material...that could be a mess. Give me a nerve block and send me home. I'd rather come back and do the acdf when I couldn't handle the pain anymore as opposed to taking the chances 10:20 mentioned. Guarantee the fusion and avoid any elements entering posteriorly.

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  13. Saw these guys at IMAST. Had some clinical data but was from somewhere in Asia. Looked interesting but wait to see uptake.

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  14. Does anyone have an image of the providence thing? I checked the site and they want you to create an account and other bs.

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  15. They are doing cases now in Europe. I heard they have distributors in Switzerland, Italy, and Austria. Not sure what they're doing in Germany.

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  16. 11:56 Your not a rep or competition and only need this for personal reason? I must assume then that you are an ambulance chasing attorney looking for all of the illeagle PODs in California so you can sue the hospitals and their surgeons for kick-backs. Leave us alone and find a real job!

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  17. 1:35... wrong, wrong, and wrong. You sound like a jerk! This blog is public...sorry fella. I'm a patient who got charged $8,000 EACH for 4 ped screws ($32K) and another $8000K for 4 set screws. I assume the ped screw does not work without the set screw so why did I get charged for them separately? Being a CA resident where the surgery was performed I have the hospital Charge Master. Now all I want to do is research and compare what other hospital's charge for the exact same product. I'm having an issue with insurance. I am smart enough to put together an argument BEFORE I file a appeal. SEE? Not everyone is a boogie man!

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  18. 1:57 - Though I don't know the name of the state organization that regulates insurance in CA, you may want to start there. Hospitals charges for devices typically have nothing to do with the brand or cost to the hospital. They charge the maximum the insurance provider will pay or in some cases bill more knowing they will receive what called "usual and customary" reibursement for the reimbursement. There are also some consumer information organazations specific to hospitals and a couple of websites to express your concerns and get helpful information from others who have experienced similar issues.

    Hope this helps,

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  19. Fella's listen...1:57 is the same blogger that stirred up a bunch of shit on this blog about 3 months ago. Same story...Got charged x amount for pedicle screws, x amount for set screws and x amount for Infuse. Is a heavy machine operator, has the master billings from insurance etc...why has this "person" resurffeced again? Don't, and I repeat, don't fall into this trap of repsonding.

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  20. Anyone heard of a company out of Atlanta named ASI? Heard it is a POD that is reaching into neighboring states.

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  21. Does anyone know the pricing differences between a 1 level Nuvasive and Depuy Lateral, for Cage, hardware only , no monitoring. Does Depuy charge a loaner fee for the retractor?

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  22. 2:53. Sounds like you are one of those TSB bloggers that need paranoia meds. You mean you aren't aware that insurance companies take forever and longer to settle claims? It has been 9 months and they still have not paid and they are now asking for chart notes and more info. I AM going to get a much larger balance due then originally told. I AM going to fight this if I can find one or more hospitals that charge a lot less for AlphaTec equip then my hospital. I'm not chasing ambulances nor am I going to sit back and get the "screws". And... I don't remember stirring up a bunch of shit. If I remember right, more then one TSB blogger thought I should be named blogger of the month. Now go take your meds or you might turn into a scary dude! And to those of you who were kind enough to give advice 3 months ago... Touche!

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  23. Alphatec is a a bunch of crooks that lie to there sales force. They will cheat you and the regional vp's are liars. Especially the feminine ones. You know who you are.....

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  24. VB, is about to announce something huge!!!!!

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  25. oh yeah? What are the VBros going to announce?

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  26. Again, I ask, can anyone enlighten me as to a few hospitals in CALIF that use AlpaTec spine surgery hardware? It would really help me on my quest to appeal my surgery bill which I am told was a "screw job" compared to others. If it is true that hospitals pay no more then $1,000 per screw and I got charged $8000K per screw, I think I deserve a chance to do my own research. Pretty Please!

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  27. 7:34 I hope that bill of your just keeps getting bigger and bigger. Be a big boy/girl and take your medicine and enjoy every tablespoon of it. Maybe you should have checked things out prior. Who cares what Alphatech, AlpaTec of Depuy charges that hospital for the screws or what the hospital pays?? really this a called a free market and if you dont like it pack your bags a feel free to move to Cananda. Pretty Please!!!

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  28. The hospital marked the screws up at least 4 X's. They will pay Alphatec somewhere around $1,500 per screw and charge insurance $8,000. Insurance will pay around $2000 per screw so the hospital settles but still make money. Next time buy your hardware up front from the company...........and skip the middleman- the Hospital

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  29. agree with 7;44! What the hposital pays for it has nothing to do with what your insurance is billed or you pay. So I personaly think, you are barking up the wrond tree trying to kick up your agruement on this Blog. Its funny cause someone posted this same question back a few months ago and I think the same response was received!

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  30. soon amazon will sell screws

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  31. You shouldn't have used a surgeon that uses a shitty, shady line like Alphatec. You should have done your due diligence before choosing a surgeon/hospital and maybe you wouldn't be in this position. I don't know one reputable surgeon that uses that crap.

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  32. 10:16 doesn't realize he is an embarrassment to sales reps in our industry. He drives around chatting on his cell phone thinking he is so very important. His posting shows his complete ignorance and adds no value to this blog or any other forum. In my territory there is a major teaching institution with respectable and reputable surgeons. They use a variety of companies. Small and large. 10:16 must be shadier than most, he just hides in the shadows of his "big" company. So anyone reading this blog should ignore his mudslinging and go back to what TSB asked. Are the people at DTRAX on the something?

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  33. Can we go back to the question as to whether Dtrax is something novel and promising?

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  34. Re: Dtrax -- I like the approach, but not the implant (possible kyphosis) and patient results are questionable. I'm not sure how many patients would be candidates (which indication?). Seems like they will need an IDE here in the US to get to market. How worthwhile are IDE these days for a $1,000 of hardware?

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  35. DTRAX interesting idea but won't be approved by FDA in our lifetimes. Next...

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  36. Good points on FDA approval. Would likely require an IDE.

    The next blog post should discuss the future of the US market for spinal implant manufacturers. The topic raises the question, "How important is the US market for future growth of orthopedic implants".

    Depuy's recent earnings report showed flat to negative growth across all ortho segments in the US buoyed only by strong OUS revenue growth.

    New Medtronic CEO, Ishrak, made it clear this week that MDT will be reorganized around OUS expansion. The Street liked what it heard and rewarded Ishark's vision with a nice rally.

    Don't get me wrong, the US market is and will continue to be the dominant market for implant manufacturers. The degree of profitability and cost of revenue, however, is becoming increasingly less attractive.

    Companies like PMT might be better off expanding in international markets with products like DTRAX.

    Meanwhile the FDA will continue to figure out which way is up. Hopefully that have it sorted out before all the jobs, manufacturing, and innovation have left the country.

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  37. DTRAX patient population likely small, as most patients with DDD and cervical radiculopathy already have kyphosis that surgeons prefer to restore to lordosis. And this procedure looks like it might actually induce a more kyphotic alignment as it doesn't restore disc height, but does distract the facets.

    So to find out how many patients may qualify, ask your surgeons how many patients they currently treat with simple posterior fusions or lamino-foramenotomies for radiculopathy without spinal stenosis. That's probably an indicator of the patient population.

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  38. Doesnt Berven remind you of a Kennedy brother with Down Syndrome?

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  39. No, he doesn't. He is one of the more intelligent and ethical guys in the field. In fact, when he supports an idea, my interest in it automatically increases.

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  40. I agree 10:54

    10:37, you're a joke.

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  41. 10:16 you are way out of line with that statement. Hundreds of surgeons put in Alphatec. I can tell you all 7 in my major big city market are not even sniffing a penny for their business. Relationships built over the years and they are solid. Some are even new guys that have strayed from one of the big boys. I won't mention who we are for the sake of staying private and don't care for back and forth crap.

    Slowly we are eating away at the big boys as they continue to pay big money for reps to leave other companies only to not produce and end up with another company a couple years later.

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  42. 10:37 your way out of line with that comment. You are a disgrace to this blog and if you are a sales professional, you have just giving us all a black eye. While I may not agree with or like some of the surgeons out there, I would never use this supposed professional blog to air that kind of comment. Way out of line!!!!!

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  43. Does Christopher Borsa shave his legs?

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  44. I would like to give you a little food for thought on a different topic other than PODs, INFUSE or Globus.

    I am a practicing orthopaedic spine surgeon. I am starting to see more and more denials of posterior spine fusion procedures, almost on a daily basis. This really concerns me, so I would like to give my perspective as to one of the main reasons I believe this has occuurred especially over the past 3 to 4 years.

    I, along with many of my colleagues, have been approached by various companies touting allograft intrafacet allograft implant products for facet fusion since 2008. The two companies that approached me specifically used the strategy of using their products in combination with a decompression, thus turning the decompression into a fusion. We, as surgeons, know that sometimes a decompression leads to instability and so it seemed like a great idea. I started using one of the companies’ products in late 2010, doing 10 or so cases on applicable patients. The company representative specifically told me to code the procedure as a ‘posterior lateral spine fusion’, a 22612, and I would have no problems getting reimbursement. From my research, I knew there was a Category III (T-code – 0221T) associated with the use of these products, so I used the correct code instead of taking the representative’s suggestion. I was denied payment on 90% of the cases, so I stopped using that type of product. The AMA states there is no reimbursement for the facility whatsoever when coding it correctly using the Category III Code. As a side note, most of the patients have returned for postoperative follow-up to find that the allograft implants have not performed up to claims made by the manufacturer.

    The American Association of Professional Coders, an association that my current reimbursement specialist belongs to, says this about intrafacet allograft implant products, ‘Do not report radiological services, bone grafts, arthrodesis or instrumentation at the same level in addition to 0221T’. But, the two companies that approached me stated that I should just code it as a posterior lateral fusion and then I would have no problems with reimbursement.

    I believe that intrafacet allograft implant products have caused harm to the spine fusion market. The two companies that approached me used the same pitch of turning a simple decompression into a fusion in less than 15 to 20 minutes. From some online research, I found 7 or 8 companies that have such products on the market. Let’s assume that between all companies that market these products, 10,000 procedures were performed in 2010 and they are of this same scenario in combination with a decompression. Medicare’s facility reimbursement of a 22612, posterior or posterior lateral spine fusion, is approximately $21,000. So, this means that Medicare and other payors saw spine fusion reimbursement increase by $210,000,000. Payors do keep a profile on us, so when they see uncharacteristic spikes in the number of spine fusions we perform on average, it will raise a red flag. In my practice, I perform approximately 6 to 8 posterior spine fusions with instrumentation per month and almost an equal number of decompressions without fusion. So, if I wanted to take advantage of the system I could just use these types of products, lie about the coding and turn a majority of those decompressions into fusions and simply create more revenue. I believe that many surgeons have been proded into coding these procedures as posterior spine fusions, and simply not listing the Category III Code.

    In my opinion, these types of allograft implants are the exact reason that the legitimate need for spine fusions in applicable patients are being denied. The simple nature of using these types of products that spine surgeons, like myself, could almost double the number of spine fusions performed annually. The payors are focusing on us when they should be focusing on the companies that market these products and the surgeons that incorrectly code their usage.

    I would appreciate everyone's thoughts

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  45. Well stated. Yes the facet dowel rage was nothing more than a smoke and mirrors coding sham to simulate a fusion procedure and obtain that level of reimbursement without actually doing one. (To wit all the interventional radiolgists and pain management physicians targeted.)

    This coding stunt is is now affecting all fusion approvals imho.

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  46. 1:17, to blame the denial of reimbursement for fusions solely on the (mis)use of allograft intrafacet plugs is simplifying the problem a little too much. Fact is that in the US between 1.5 and 5 times as many patients get a fusion than in European countries. This huge difference cannot be satisfactorily be explained by us having worse spines, or by Europeans being massively denied service. Many publications point to monetary incentives playing an important role in the decision to offer surgery. That being the case, inevitably patients get surgery that don't need it, and it should be no surprise that their results are overall pretty disappointing. What is surprising is that it has taken the insurance companies this long to take a closer look.

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  47. 1:17 interesting commentary on intrafacet allograft implants.

    fyi - DTRAX is a titanium implant.

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  48. .....And the hits keep coming: One of the main facet dowel players is scrambling to put together a POD as we speak!!!!

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  49. Great to get a surgeon's perspective thanks 1:17

    I agree 2:34 that is only one (small) part of the problem with difficulty in getting surgeries scheduled and paid for. A huge part of it is insurance companies can increase profits by holding line on benefits and increasing premiums. This makes the bottom line fatter. That is a huge part of it.

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  50. Yes, very refreashing to hear from an actual surgeon and thier prospectives. While sometimes I may not agree with everything they say, hey like I have been told many times in my career "how many of these have you implanted in an actual live human".

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  51. Anyone heard rumors that Zimmer Spine is making agent changes on the West Coast/California?? Head they have lost much, if not all thier business there and the current agents are on the chopping blocks. Any one ahve any insights...oterh than then the normal "ZS is dead weight etc..."

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  52. Now all these guys need is five years and a mere $100 million dollars to do complete an IDE study, submit the PMA, fight with FDA for a 50-50 percent chance of getting approved.

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  53. 2:44 PM

    What facet fusion company is attempting to put together a POD? In my opinion, any existing distributors of theirs should cease selling their products immediately.

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  54. Roses are red,
    Violets are blue,
    Spine has become a disgrace
    & so have all of you.

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  55. 5:43 PM

    Spine is the field we have chosen,
    and, simply because we love it.
    If you don't like the people or attitude here, well, you know where to shove it.

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  56. 6:15

    Love it? Hmmmmm,, I guess NO ONE does it for the money,,

    There aren't many who LOVE it. You're a fool.

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  57. 2:34,

    This is why Unique Device Identification is coming down the pipe in 2012. It's a smoke screen for CMS to get a handle on this very issue. Inventory tracking and transparency will become a must and if not you will be fined...heavily!

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  58. Given proper patient selection, facet fusion can be very effective. Furthermore I agree with the earlier poster that the reimbursement issues we face are a result of many factors. If one has poor outcomes owing to a certain technique or product the onus is on the surgeon to try a new approach. Why not base reimbursement on some surgical result metric? If a patient does well after a facet fusion, motion sparing constructs, ACDF, etc etc hasn’t the goal been achieved? Reimburse quality surgical result (and yes, I recognize the difficulty of implementing this concept) and the struggle between surgeon and insurance company would be greatly reduced.

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  59. Hey 6:25 I do this job, and have for over 13 years cause I love it! Yes, the money is grest, the flexablity to spend time with my family is great, being able to show off to my friends what I do/sell is great. But after I became a patient 7 years ago and have a 360 at L5-S1 done on myself, I was able to ahve a greater respect for this business the patients and the surgeons performing these surgeries. If you want to call someone a fool, you need to look no further than yourself. It's fools like you that do it only for the money and your time is running short my friend...very!

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  60. Nutech Medical's Nufix facet dowel. Nutech is the company that is setting up the POD. Their grafts are cut by Lifenet. Originally, Nutech was the national distributor for the TruFuse facet dowel until they decided to steal the instrumentation designs and create their own. Now Nutech is paying royalties to MinSurg (TruFuse).

    The use of facet dowels as a fusion device has definitely hurt the market. FYI. Nutech is also scamming the market with their NuCell (amniotic mesenchymal stem cell) product. What a joke!!!

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  61. What about coding ILIFs using a fusion code?

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  62. There a facet company in San Antonio called medical technologies- they also copied that design and developed a company. Those facet plugs cost $40 to make. Im rep in San Antonio and I have seen several charge sheets. They charge hospitals $5500 for two grafts.

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  63. http://www.kens5.com/news/health/SA-company-marketing-surgical-wedge-made-of-human-bone-69122742.html

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  64. Anyone can create a machined facet dowel. These companies don't need to go through an IDE since it is bone. No FDA approval. Surgeons are coding for post fusion code 22612, DRG 459 or 460. The Medicare reimburesment is $21,000 without complication or comorbidity and $33,000 with complication and or comorbidity. It takes 10 minutes to implant these machines allograft facet dowels. It's the biggest sham in modern day spine surgery.

    The biggest problem with these dowels is that they migrate. I have seen migration rates as high as 50-60 %.

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  65. 2:44 PODs will surprisingly come to the rescue of the American public. The Senate knows that Medtronic and Depuy-Synthes have controlled and monopolized the implant industry through consultancies. The only way to break this is through PODs. That is why PODs will survive. To end the Big Pharma position that the Big Device companies have. Any doc using Medtronic or Depuy should be investigated for possible ethical issues.

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  66. Watching the Train WreckAugust 25, 2011 at 9:55 PM

    Nutech is indeed the company that stole the TruFuse design, then got sideways with Bacterin in a lawsuit and now has them cut by LifeNet. NuTech is also setting up POD's using Spinal USA implants.

    Interestingly, their KOL for NuFix, Dr. Mark Prevost, all but abandoned pedicle screws for the last 4-5 years. Then he had a sudden change of heart, presumably due to outcomes and stopped using Nufix for all of his fusions and returned to pedicle screws. A scant 3 months later, he was using Spinal USA screws sold to his hospital by, you guess it, himself and Ken Horton.

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  67. I would like some clarification on the dowel coding. My understanding was that the AAOS coding advisory board had the T-Code implemented only for the percutaneous procedure (to block pain management docs from billing for fusions). The open procedure was still advised to use the fusion code. Is this bad information?

    Another point to consider regarding facet dowels is that hospitals love them. The hospitals will boldly tell you that the docs using the dowels are the lowest resource consumption spine docs in the facility. The problem is that most of the docs are doing these fusions on patients that normally would have only gotten a discectomy or hemilam. Regardless of those details, the hospitals love them because their reimbursement goes up to the fusion DRG and the cost for the fusion is lower than traditional screws, unless you fuse more than a couple levels. I don't think my hospitals have any clue that the microdisc volumes are down and fusions are up by the same number.

    As far as companies that make the dowels, there are many. The barrier to entry in the market is negligible. The big boys have them too, but they don't make it very public. MDT and Synthes both have them.

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  68. 9:41
    It amazes me that so many of you think every surgeon only uses products from companies that pay them consultancies. I have been in this business for 15 years and the number of consultancies offered has been nominal. A few guys getting paid to be lab faculty here and there, a short term stint for an advisory panel for a product there, but no rampant overuse. Im sure it is more prevalent in many places, but I think WAY too many of you assume that business you can't get is bought and paid for. I know that I have been accused of buying docs when I took some business. But the only person thinking that was the guy whose business I took. (don't even start with the "Wow Mr Bigshot" replies, I've lost business too with no consultancies to blame).

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  69. 10:24 this is a blog and opinions are opinions. Its not USA today or WSJ. When the reporting becomes mandatory though, you will see how many names are listed.

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  70. 4:43
    It will be interesting. I have perused the MDT list online and found no surgeons in my area. There were a few on the cardiac side, but none in spine.

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  71. And by the way, opinions are often wrong. In situations like this, my opinion is that many reps use this as a scapegoat to explain why they lost business because their competitiveness won't allow them to believe they got beat. And since they can't prove, or don't know, that the consultancy DOESN"T exist, they resort to assumptions that make them look better in the situation. I've been guilty of making those assumptions, but I kept it to myself unlike the guys spouting it over the blogosphere (and to their manager, I'm sure).

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  72. 10:02 PM

    FYI - The T-Code for facet fusion with allograft dowels, etc applies to all surgical procedures.....open, minimally invasive and percutaneous.

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  73. A sham is a sham! It's one thing to have high profits AND quality patient outcomes. But w facet dowls the patients are getting screwed! I've revised dozens in the Austin, San Antonio area. I'm quite certain most of the surgeons using this product have some kind of financial ties w the company in San Antonio.

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  74. Any further news on the POD situation in SC? Something of that scale could be a precendent setter.

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  75. Rumor has it that Horton and a couple of his managers have parted ways. Anyone have insight? Is it just a matter of Ken getting to close to the fire?

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  76. When you Horton and a couple of his managers, are you referring to Tod and Greg?

    Ken Horton began selling bone out of his trunk. Now , he is the CEO of a multi million dollar sham empire Nutech. NuCel (sham stem cells), NuFix (sham facet dowels) and now they have a product called NuShield ( sham on lay graft and wound covering).

    When is the spine world going to wake up. Anyone want to purchase some property in the 9th Ward of Baton Rouge??? What a joke

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  77. I apologize for the sentence mistake. Were you referring to Ken Horton and his managers Tod and Greg?

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  78. Does anyone have insight on ISP's? Interspinous Process Devices. Lanx has ascended from a small obscure $10 million corporation to a $50 million corporation due to one product. Their Aspen ISP. Is it a Sham or legitimate device. Once again, it has been afforded the 22612 fusion code.

    Almost every company has followed with their own version.

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  79. X-Stop was the first one, I think. I'm not a big fan of interspinous process devices. The biomechanics are all wrong. Wrong center of rotation, and the spinous process isn't designed for load.

    OTOH, the surgery can be almost done in the office.

    /engineer

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  80. Sorry, have to go back to the coding issue for facet fusion. First, if a rep gave you specific codes for billing, that is now against the law accourding to the Medical Devices Act of 2007. (a few years ago, it was just a rule). And, providing coding that "sounds like" something similar to attain reimbursement is insurance fraud. The company, the surgeon and the hospital can be held liable. While the likelyhood of a person going to jail is low, the fines around it can be harsh, scrutiny going forward intense, and time waisted emense if you are audited. Reps and Docs, don't get caught up in these "pixie dust" schemes, it's not worth it.

    As far as the numbers of fusions in Europe vs. the US, there a a number of reasons, not related to income, that affect fusions rates. First and foremost, in most European societies, pain is NOT a disability - that's primarily a US issue - people here are not willing to change life style due to pain. Second, and more importantly, in most European societies, where health care is government controlled, medical health institutions are willing to put considerable time and money into conservative care and aggressively treat back pain with all other methods first and surgery as a last resort. The last is financial. Since the greatest majority of surgeons are government salareied employees, they get the same amount of money whether they treat patients conservatively or do surgery. Therefore, surgery is the last resort. Our get rich quick, take a pill society without regard to cost is a motivating factor for Docs and patients. And though there are too many, the number of surgeons who are in it purely for the money have tainted those who actually are trying to do good for their patients. I found out something interestly in the past few month, in a review of the outcomes studies for Europe and PAC Rim, their outcomes for fusion are not any better or worse than the US. But in looking at the pre-op VAS, ODI or similar scores, their patients start out worse than those in the US.

    Food for thought.

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  81. 8:45 - great post and perspective.

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  82. 9:55 - allow me to suggest a clarification. A KOL (Key Opinion Leader) is decided by the surgical community as someone who carries influence in the group. A "champion" is someone who promotes a particular product. I think you mean the latter, and the distinction is huge and increasingly underappreciated in our field.

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  83. 8:45 and others with a brain,

    Unique Device Identification (UDI Mandate 2012) will clear up all of this mess. It will stabilize reimbursement and align company goals with patient outcomes. Google UDI FDA for more information. If you're not tracking your medical devices you better start looking for a solution before the big bad wolf blows your house down!!!

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  84. 11:44 - Do YOU have a brain, or was your message sarcasm. Just because now we'll be able to track devices instead of classes of devices, what makes you think that all of the discrepancies that ACTUALLY contribute to the mess will be assuaged. For example, the FDA says "safe and effective" but insurers say "experimental", surgeons say "standard of care" but insurers say "overused", etc. keeping in mind that all are looking at the same exact data! The challenges in the healthcare system are a result of misaligned incentives (both financial and professional), and have little to do with having insufficient data to work with. In fact collecting and analyzing the data is only going to make things more expensive.

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  85. Does anyone know if the mandated FDA UDI will apply to allograft?

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  86. 1:32,

    That has to be the dumbest assessment I have heard in a very long time with regards to this issue. The reasoning behind the system is to iron out the very discrepancies you are explaining, essentially level the field so that nothing slips through. In other words make the system completely transparent. After the data is evaluated you will see changes of epic proportions, some for the better and some not but I guess that depends which side of the force you're on.

    1:41 - your answer is yes.

    People please investigate this topic further. Google it, read the FDA web-site on it, speak to operations about it and if you're a distributor, yes you will be liable as well to maintain a database. ALL product will be tracked and all of these issues will a) become obvious faster b) resolved quicker c) recalled instantly or d) stopped before making it to market.

    The spikes that 1:17 speaks of will never happen again, or at least CMS will stop it much sooner and you won't see too many companies spending R&D $$ to chase something where reimbursement will end almost in an instant. Feel free to ponder on how this too will affect the organizations you work for.

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  87. That will happen just about the time our country figures out a balanced budget. On pins and needles over here.

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  88. 9:58
    Point well taken and I agree. I fell victim to the marketing department definition.

    Just for shits and giggles, check out their video.

    http://www.nutechmedical.com/catalog_nufix.php

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  89. I just heard Nuvasive is looking at Paradigm Spine. Data must be worth the $ Biatch

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  90. NUFIX - Non Unions Found on Individuals' X-rays

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  91. Re SCSS POD vote... I suspect we will know more when they meet again Sept 17. Interesting their trying to cut out the very people that fund their meeting.

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  92. 2:45,
    Why do I have the feeling that guys like you are the reason we haven't figured out a way to balance the budget yet?

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  93. Spine Blogger:

    How about a post on the potential Nuvaive acquisition of Paradigm? What are your thoughts?

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  94. What purpose would Nuvasive acquiring Paradigm serve? Nuvasive has Affix/ ILIF,, why would they want CoFlex? Perhaps some interest in DSS?

    Not going to mean much even if an acquisition does occur.

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  95. Why would they be interested in DSS? The field of dynamic stabilization is dead!

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  96. Yes. Horton started a POD and is purchasing the product from the "POD Godfather" SpinalUSA.

    Prevost, MD has been Horton's bitch for a number of years. Back in the day ... Prevost's wife was his Theken distributor.

    Prevost, Bassett, Jones, Swaid, Maddox (father/son with sister/other brother as "reps") and soon to be Warren. Alabama is chock full of spine surgeons with their hands out. No wonder the WSJ has set up camp here. I expect surgeons and hospitals to be exposed with the trial lawyers coming in to finish them off.

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  97. 12:24 My point exactly. Why would Nuvasive be interested in Paradigm, they have notjhing to offer Nuvasive.

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  98. huntsville AL is the shadiest spine market in the world

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  99. 100th comment! Woo hoo!

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  100. SC is trying to come in 2nd

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  101. All spine comments & perspectives aside,, Let's take a few moments to hope that all of our fellow members of this community are safe after the wrath that Hurrican Irene left behind this weekend. For those that may be facing challenges or difficulties due to rain, flooding, wind & storm damage, we hope that you & your familes are safe.

    Peace.

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  102. 2:15--
    What makes you so sure the FDA's infamous UDI will apply to allograft and biologics?

    These implants are NOT considered "medical Devices" and therefore probably do not qualify. I agree that there needs to be more oversight. However, lumping tissue grafts in with facet screws is probably not the answer.

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  103. In regards to Nucrook Medical, it's all true. His southeastern manager left a few months ago. He recently lost his arthrex distributorship to his long time manager. Get ready he is launching a new snake oil with no data. They are also launching a new graft for dura covering. Funny thing, Nutech is developing this all of this why under contract with Mimedx. Same ole song and dance as before. It won't take long for another lawsuit. If Todd and Greg were smart they would jump ship. The sad thing is all the reps who stayed with him so long. They have been screwed by his wife on commission. These reps are really good and should get out before it's to late! These poor kids have busted there ass for that clown. I know a few who have lost business because of ken. These reps are gonna hurt him when they leave! That you can count on!

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  104. don't sugar coat it, tell us what you really think about nutech

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  105. 9:56 Sounds like the "Southeast Manager who left a few months ago," or maybe his "longtime manager" who he lost his distributorship too, or are they the same person????? Who else would call grown men "poor kids"?

    If he is stealing all these products from other companies, how does he sleep at night?

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  106. yea this same clown from Nutech tried to get me to sell their tissue here in California and then tells me they are short on 7,8mm ACDF grafts but have plenty of 9's and 10's WTF...when was the last time you saw a 10mm ACDF graft implanted, other than a corptectomy??? Give me a break. And then turns around and says they only have 4 instrument sets avialble to the field. This ship is sinking fella's.

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  107. 1217- the southeast manager and long term are different. The long term was his arthrex manager. He is now distributor for arthrex. Nutech was a multi-million dollar acct for arthrex. Poor kids are his 10-99 in the field. They have stayed loyal through the years. They have been lied to and given empty promises. Most of them in there twenties. These are some of the most highly trained and adapted biologic specialist. This is from years of experience and not a credit to Horton. They are mostly in Ga, Fl, Al, and La. The one in Georgia and Louisiana especially. Those are the ones that need to bail.

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  108. This comment has been removed by a blog administrator.

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  109. This product is a joke. I completely agree with other posts on here that nothing looks to keep this from migrating and I'm pretty sure could only be a 1 maybe 2-level MIS device and nothing else. What could they possibly charge for that? I wouldn't pay more than $500 to use both of those pieces of shit. The Stupid Idea Store called. They want their stupid idea back. The Spine Surgeon

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  110. Ken is a goof ball! looks like a short fat Elvis. Saw him at NASS sport some versace eye glasses with big golden lions on the sides some gaudy gold jewelry. He even had a super bowl sized ring on with his nuteck logo on it... walking around bragging about his private jet blah blah blah. WTF!

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  111. Don't forget the yellow sport jacket he had on and the lizard-skin boots.

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  112. The ignorance and misinformation from you, all-knowing, foremost authorities, is a joke to read. Bad mouthing docs, companies, owners, managers, wives, and reps... how sad and pathetic. and your take on where the market is heading... or what works and what doesn't have a chance... I'll be sure to take that into consideration.

    If you don't know what you're talking about or what is being discussed and aren't smart enough to understand an explanation and then regurgitate it… DO NOT DO IT.

    thank god the majority of the posters on this site are so far down the totem pole in their company and the bureaucracy in place will keep you from ever making a decision that will affect your doctor and more importantly, the patient.

    I repeat, YOU WILL NEVER MAKE A BUSINESS/ PRODUCT DECISION THAT WILL AFFECT THE CASES YOU COVER, IN THE LIMITED TERRITORY THAT YOU HAVE TO SERVICE ,for the few points you get. If you can't spot the sucker…

    How is it going- calling on your territory of eight docs? What are you going to do now that your "best friend" and busiest doc up and moved- or just dropped you ("it's nothing personal, it's just business") Did you fill out your hands on report with how many times you physically touched "your" doctor this week?

    You are proof that it is better to be lucky than good

    Ask your boss to ask their boss, to ask their boss, to ask their boss, what they think about DTRAX.

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  113. TSB, can we start a comment section just on Ken Horton and NuTech? It seems to be a popular topic.

    The man is a walking "triple threat": POD's, Snake Oil products, and bad clothing/accessories.

    Those three areas will provide provacative insight and side splitting humor regarding the seedy underbelly of our industry.

    A Pulitzer Prize awaits you!

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  114. 8:56.......get over yourself

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  115. I saw Ken's yellow sport coat at AOS and I thought he was possibly a college bowl representative who had got lost but I couldn't figure out why he was giving all the doctors hundred dollar handshakes.

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  116. For crying out loud, how about some new material Spineblogger!

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  117. Horton aside, we should be giving all the facet fusion companies that market allograft dowels pure hell as I believe they are the direct cause for insurance companies denying fusion procedures. My docs have revised so many of these cases it's pathetic. I just saw where one of the companies is now saying they have come out with version 2, but in the article I read it doesn't say why they went away from version 1. That's funny in itself. What does this mean, version 2 offers twice the phony coding or it pops out twice as fast? Someone should write Medicare and the other insurance companies about this phony market segment and have it investigated.

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  118. WSJ is in Huntsville, AL

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  119. no one cares about horton or most any other one individual in this market

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  120. Asst to the Regional MgrAugust 30, 2011 at 10:41 AM

    Agreed, 10:15.

    7:34, not trying to defend the FF market, how do you do a revision on a facet fusion and couldn't the same be said about the newest cervical plate, screw, PEEK, etc...

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  121. what about docs burring the facet, packing it with bone and billing a 22612?

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  122. 10:44

    Burring the facet and billing a 22612 is in fact a legitimate fusion. Unlike allograft dowels, it has been done for years, has been proven effective in actual peer-reviewed clinical studies and does not add $4,000 - $5,000 to the case like a pair of the bones dowels do. It doesn't take bone dowels to do the job, and those that are touting that 'bone dowels add stability' are full of themselves. There is no stability when they pop out, which I've heard is usually not long after surgery. I agree with what others in this blog have said, it seems to be nothing more than a sham / scam procedure to get a code.

    Where is the clinical data on these facet dowel procedures that would even come close to past studies where the facet joint was simply burred and then packed with local autograft? Apparently, it must not exist or one of these sham companies would have produced it by now.

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  123. 11:40, I agree as the studies on fusion of the facet joints are numerous and they required nothing more than a little carpentry to effect a positive result. Allograft implants are not necessary and only add cost to the overall procedure. Stability can be achieved by just bracing the patient over a 6 to 8 week period and as most know, autograft is the gold standard in fusion procedures. Cortical allograft takes 6 to 8 months just to revascularize and would never be responsible for the fusion in the first place. In addition, the shape of the dowel has little to do with anything other than just being a marketing pitch.

    It seems like most of the companies behind these products are touting, well Mr. Surgeon, if you can drill a hole, then you can bill a fusion'. This is one of the reasons our market is f'd-up in the first place.

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  124. Facet fusion with allograft pegs is a dying market.

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  125. 1:17 is the sales manager you're referring to that works for Horton the one that is really tall, walks with a hunch back and has hair down to his ass?

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  126. TSB, can you please write a blog on another topic? Facet fusion is a dead space and DTRAX has been discussed enough. How about maybe a discussion on what you think will be the next big thing in spine?

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  127. How about a blog on what companies will fail next? We could take bets and have someone sponsor a prize for the one that predicts it correctly.

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  128. there are also results that show a facet joint- contralateral to the TLIF side will fuse on it's own- untouched. no 22612 needed.

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  129. 1:34 you're ignorant as hell. If you do a TLIF, then what do you think that is...........it's a fusion or in other words a 22612. The interbody space is the 22612. Shows what you know about spine surgery and coding. Now, go back to selling your facet fusion allograft dowels and other snake oil remedies withour clinical science.

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  130. 1:34 TLIF - Transforaminal Lumbar Interbody Fusion.......22612

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  131. 2:16, you are wrong- interbody is 22630. 22612 is post lat

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  132. I know why we don't have a new topic yet......No ONE has asked the often cited, "When is Globus going public" in this thread that I recall.

    Now, lets move on MM, please??

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  133. 2:36 I stand corrected, it is a 22630. But, a fusion code can only be reported one time at each level, right? So, that would make 1:34 still an idiot.

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  134. Newsflash, I just heard that Ken Horton is buying Globus.

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  135. Good grief ... Please enlighten us to all the peer-reviewed published data regarding facet fusions. Hint: there is none. "burring the facet and packing it with bone"? There are studies? BS.

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  136. 3:07, evidently you don't read too much as one of spine's most noted biomechanical authorities, Dr. Edward Benzel of the Cleveland Clinic, just had a study published in the Journal of Surgical Orthopedic Advances in 2010. It is entitled, Noninstrumented Facet Fusion in Patients Undergoing Lumbar Laminectomy for Degenerative Spondylolisthesis. Dr. Benzel has numerous other papers also on the topic of facet fusion using this method.

    His technique was described as, "Following decompression, a capsulotomy was performed in line with the dorsal facet joint. An 8-mm burr was then used to remove approximately a 0.8- x 10-mm trough (about 5 mm deep) of the bone, incorporating both walls of the dorsal facet joint. Following this, local autograft from the decompression was finely ground and packed in this space as tightly as possible".

    All patients underwent postoperative bracing with a lumbar corset during ambulation for 2 months.

    Dr. Benzel's findings stated, "The data presented here strongly suggest that patients who attain stability (either by bony fusion or stable pseudarthrosis) have a much better clinical outcome than those patients who develop or continue to exhibit instability after a decompression via laminectomy for lumbar stenosis. Thus, in symptomatic spinal stenosis, uninstrumented facet fusion, along with decompressive laminectomy, offers the advantage of stabilizing the spine (via bony fusion or stable pseudarthrosis) without the extensive dissection and morbidity of dorsolateral fusion".

    See, no bone dowels or hokie technology to stabilize the joint was needed. I'm glad I could enlighten you on this subject!

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  137. Wow 3:07, you just got your ass handed to you! Great job 3:44. I found the Benzel Abstract online and I am actually going to purchase the full study now.

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  138. WSJ in Huntsville, AL? How would you know that?

    Is the OIG (HEAT) and DOJ there as well?

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  139. I don't know about the WSJ or OIG being in Huntsville, AL. What I can say for sure is that the Federal Unit to Catch Ken is definitely there!

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  140. 4:24, that is bold to say- last time I checked, NuTech isn't located in Huntsville.

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  141. 2:54, you can't repeat the same code [in a procedure- a la, addtl segment coding and modifiers]. 22612 uses the terms, "posterior or posterolateral". 22630, "posterior interbody technique, including laminectomy and/or diskectomy to prepare the interspace at one level." 22612 is often used in place of 22630 as it pays better. But 22612 can be coded with 22630 (yes together).

    You are both kinda wrong and kinda right

    That said, 1:34's statement is legit about omitting the 22612 and you are kinda an AHole

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  142. None of the stuff you guys are saying about wsj or the Feds being in newtechs business is even remotely true. Sure Ken is a very colorful guy but aren't most business owners. You guys are taking cheapshots. I know Ken and he's a very nice person. Not one shred of truth to any of that. Ken is successful. You disgruntle x employees need to move on w your lives. Get over it. Start your own company and compete. But don't go on a blogg and bash. It's truely the lowest form of life.

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  143. 527

    Just because you own a business doesn't mean you should dress like a pimp. Unless, of course, your business is pimping then by all means do so.

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  144. News Update:

    Having finally unloaded its Arby's brand,, The Wendy's Corp. announced today that in an effort to diversify its assets, it would be looking to acquire Globus Medical during Q4-2011.

    There ya' have it folks, you heard it here first.

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  145. Asst to the Regional MgrAugust 30, 2011 at 6:01 PM

    Just because you have no class doesn't mean you should bad mouth someone.

    is this forum to discuss spine or fashion?

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  146. Fashion sounds fun. Have any tips?

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  147. 3:44 the Journal of What? That's hilarious!!! Good luck showing that to data to all your thought leaders. I mean with hard core numbers like "much better" ... 99.5% of people have never heard of that journal and Benzel isn't the lead. The dude probably just used his lab.

    Ohh one more thing. Break down the data and you'll see his data isn't that great. I don't disagree with the treatment in elderly degen spondy patients but when your significant data is "much better" from an already small sample size .... hmmmm you won't being seeing this at CNS or NASS anytime soon.

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  148. 5:27 The lowest form of life form in my opinion is the person who pays doctors and the doctor's who accept money to put sub standard products in patients. Remember the old axiom of your grandmother being the patient. I am not talking about Arthrex (which presumably Ken lost for lack of sales or his sleaze factor) but I am talking about all the other products he pimps such as the bioillogical products he has poorly copied and Spinal USA products that suck. And yes I can say that with some confidence having been in some of those cases selling another product and seen common instruments needed and not in the set and seeing first hand the quality of products. You sir, are the lowest form of life as presumably you use these products or endorse these business practices. I can only hope you and Richard Scrushy become good friends. You know you can't wear two thousand dollar shoes and fly in corporate Jets from jail Mark. I would also hardly call buying business competing. Why doesn't Ken try competing like the rest of us? Hint, because he tried that at Zimmer and lost. I realize this is Alabama but it would be nice to think we don't live in a third world where corruption is so rampant and defended as good business practices. You do realize there are a lot of people who have suffered a tremendous amount of pain and people like Ken and you have bilked the system. Sleep well do you? Of course you do and that is the problem. Well you had better hope I don’t get too disgruntled or you won’t because someone somewhere is going to turn up the heat eventually. Most criminals get caught.

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  149. MM, what are your thoughts on The Mazor Renaissance Spine Robot? The next big thing perhaps? Will it follow the same successful marketing path as da Vinci? You know..."they have one so we need one". Seems Renaissance has much better clinicals than da Vinci ever had, or has to date, yet it's only in 5 centers in the US. Why? Is it that this effed up economy combined with Obamacare that hospitals aren't willing to shell out $750k. Personally, if I were a hospital administrator, I'd buy one tomorrow and market the he'll out of it. But what do I know? Thoughts?

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  150. 6:57 I have seen the Mazor robot in action,, not that impressive. In fact, I've seen it used in about 6 cases, in 4 of the 6, it took so long to register the landmarks that the surgeon simply gave up and did the case w/ out it.

    Seems like a whole lot of overkill for very little benefit. Throw in the big price tag and they've had a real tough time justifying the cost. Sorry if you're tryin' to sell it as I think you should consider moving in a different direction.

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  151. Im not involved with Nutech, but i do carry spinal USA, among other lines. What products suck? What hospital were you at? Who was the doc- Better yet who are you? If you're going to make [false] claims- be a professional and don't hide. Guess what, I'm not involved with a POD, nor are my docs being paid by spinal USA. They like the products. Not everyone likes them, clearly. For arguments sake, you win, your bag and company are the best in the biz. Feel better?

    This industry is competitive enough. Try selling with integrity and professionalism. Don't bad mouth a company you know nothing about.

    And do us a favor, keep your retort of, "talk about professionalism and spinal USA" to yourself. It is your opinion and you are wrong.

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  152. My two cents. Facet fusion has it's place in spine for a small population of indicated patients. However, this type of fusion can be achieved without the use of costly dowels. There's simply no real science behind the madness with the dowels and no justification for the added costs.

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  153. 6:32 - Simply stated, Dr. Edward Benzel is a noted researcher and spine biomechanics specialist and his work should be respected. Dr. Pateder studied at Johns Hopkins.

    Dr. Benzel's CV reads like the Who's Who amoung world thought leaders in spine. And yes, I have presented this article to several neuro and orthopaedic spine surgeons and it has made a difference in their thought process regarding facet fusion. Surgeons that had previously used bone dowels have stated that this method of facet fusion makes even more sense for applicable patients and they don't have to worry about post-op dowel migration.

    I did break down the data and it's better versus any data that I found from the facet dowel manufacturers, which I can't seem to find any.

    In all reality, you're probably one of the cult members that bought into what the facet fusion allograft companies are touting, which is really sad. A scam is a scam and that's the only way to call it. Did you seem to forget that in the end it is all about the patient, not the money. If you focus on patient care, the money will come and that's a fact.

    Can you show me an independent biomechanical or clinical study from one of the facet fusion companies? The key word here is independent and the answer is you cannot find any independent real study or data. The only studies my docs have seen, and yes some of them were previously interested in facet dowels, is either sponsored by one of the companies or the surgeon that authored it has a vested interest in that company. From some simple research it appears that facet dowels first came on the market sometime back in 2006, so you're telling me that 5 years later there's still no clinical data that is from an independent source? Oh, I forgot, there was that one study from pain management guys who said they like the potential of a fusion code, I mean the potential of a new procedure.

    I had rather believe 'much better' from a noted researcher than to believe a piece of cortical allograft is actually going to hold an articulating joint together and fuse it. But, it your case, I totally understand.

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  154. Wow, this blog has went from cervical to lumbar on facet fusion. What happened to the focus on DTRAX?

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  155. I am the surgeon that wrote in previously on this blog about facet fusion. The blogger that referred to performing a facet fusion with a burring technique is 100% correct. It can be performed effectively, especially in open procedures. It's more difficult to perform this in a minimally invasive type of procedure, but can still be done. I've used a 5mm to 6mm burr and went down into the joint about 8mm creating a void space. I took a little bone from my laminectomy and packed it into the space I created using a bone tamp with a round end. Then I took just a small amount of DBM and tried to pack a little in the joint and left the remaining portion on top of the joint. I estimated the facet gap space to be less than 2mm. Postop CTs taken at 90 days exhibited fusion. This method works well, but it's just a little old school, takes longer but it doesn't cost an arm and a leg either. Sometimes we, as surgeons, just don't want to take the time to do this extra step.

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  156. 8.04 Saw a surgeon perform a similar technique in Texas this week with a really trick system with tubes. It was slick and I had never seen it before. The surgeon said it was a prototype that he had made.

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  157. Mr. Spinal USA- puhhlease! Perhaps your new to the Spinal team but I've seen them across Miss and Alabama and their tactics are the reason the feds and WSJ are all over this area. Recent marriage with Phygen ("Physician Generated Income!) has them selling to the Atlanta and Chattanooga docs with their hands out. I'm with you- the products are average. But I'd love to hear the percentage of guys using who are investors or POD's. Anytime your team wants to release that- we're ready.

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  158. Spinal USA Rep - You have doctor's that use your product that aren't in a POD or getting paid by the company? You might want to consider hiring a sub rep for your dad. The big companies have their faults but even at their worst they weren't paying a majority of doctors to use their products and they put money back into legitimate R&D. What's your name? I am sure WSJ would like to interview you as the one rep from Spinal USA whose doctor's don't participate in a POD or are not getting paid by the company. I know, your going to sue me. I am sure you will have lots of time to study for the bar at the jail library. Is it just a rumor that Spinal USA was raided several times and had their doors closed? How did you get replenishments to ship for all your docs if that was the case or did your doctors just implant a size close to what they needed? You guys make Alphatec look legit and that is hard to do!

    This is the problem, known nefarious criminals defend their position and honest people who care about the decay of a market, a county and patient care are criticized for being unprofessional. When did forming PODs and paying physicians to use products become professional? Sometimes I can’t get my mind around this business. I guess I should start robbing banks and holding up people and bloging that everyone else should compete for their own money and quit being unprofessional and critical of my tactics. I would jump up and down with a pizza or sandwich sign to make a living before I would sell products for Spinal USA but I guess you don’t have that many options. When this spine bubble bursts and it is bursting what will you do to make a living? Let me guess before spine you sold mortgages and after spine on to the next bubble where you can scheme the system.

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  159. What's wrong with selling mortgages?

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  160. 6:57 you may or may not have seen the Mazor robot in action. Your comment seems a bit dramatic. You also sound threatened by it. Are you afraid of loosing some of your metal business to them? If speed is a problem they will address it. It's coming my friend, whether you like it or not. And I can tell you, should my child develope scoliosis and need surgery, I'm finding a surgeon that uses Renaissance. And no, I dont work for Mazor, but I wish I did.

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  161. SpinalUSA rep,

    There is not one surgeon using SpinalUSA that is not part of a POD. Period. End of story.

    When that house of cards falls down, good luck getting another spine job with SpinalUSA on your resume. You're a set replenishing half-assed coverage bitch with zero credibility, skills, and integrity.

    Eagerly awaiting the WSJ piece. Maybe then the hospital administrators will realize how bad they've been had ... The trial attorneys will be next to rip these guys apart.

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  162. Just heard that Ken Horton bought a new silver sportcoat, new nugget watch and big gold ring in preparations for CNS an NASS.

    NuFix has put him in just that, a new fix and NuCell will be his home (in a new cell) when the DOJ and OIG get done with him. Looks like he did have some insight on his future when he named his last two products.

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  163. 11:23 now that's funny. it's time that someone held horton's feet to the fire. however, snakes do have a way of slithering out of these typs of situations.

    has anyone ever noticed that todd, ken's sales manager, wears the same brown shoes to every society meeting?

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  164. Blogging live from a surgical procedure in Florida. Surgeon is using some new system for facet fusion. It doesn't contain an allograft dowel or implant whatsoever. Looks like he is using some type of cement or something. Don't see a name on the product though.

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  165. Desperately
    Need
    New
    Topic

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  166. Bacteria found in Panda droppings could lead to a major new source of "biofuels" produced but from grass, wood chips and crop wastes. Sure beats the heck out of some BS facet system or even worse, some new revolutionary pedicle screw!!

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  167. The wonderful world of the “rock-star” medical device sales rep is in danger of becoming extinct. For those of you still knee-deep in the industry and in a current state of denial, please bear with me as I share with you your demise. Some of you are probably waiting around for the next “hot thing” or that start-up paying big $ and promising you that they are going IPO. In the interim, you are at your third company in the last five years walking a round like a zombie from hospital to hospital because you know that this ship is taking water too. You have either just left another National Sales Meeting (NSM) or are headed to one and know full well that it will be a waste of 3-4 days of your life because you are totally disengaged. I bet you are real excited to hear another round of marketing presentations by some folks that have little clue as to what actually happens in the real world. I forgot about the drink tickets that they now give out too to avoid any mishaps like last years disaster at (NSM). Wake up call !! Lets focus a minute on your current reality.
    Hospitals do not want your kind in their facilities anymore. You are probably wondering what “your kind” is but you know that sales rep who walks around the hospital like they actually work there. The kind of sales rep who actually starts to believe that they are as critical to the success of their surgeons’ cases as the actual surgeon. That sales rep who wears scrubs to and from the hospital and down deep starts to believe that they actually add value in the operating room by merely standing in the back of the room. The sales rep who feels the need to share their knowledge with the rest of the sales force as to what it takes to make it happen on a consistent basis without even being asked. Really? You know that sales rep that is paraded around like a show horse because they have figured out the secret sauce (according to sales management) to making their # quarter after quarter, year after year etc.,. Come on everyone; just do it like him! Do you happen to work with anyone who fits this description? I bet you do. The truth hurts sometimes but sunshine is often the best disinfectant. Your world has changed and you just don’t see it. In some ways, you are not that much different from a vampire who hides in a coffin to avoid the realities of the world.
    Most hospitals now understand that the quickest way to control cost is to limit your availability to their physicians. Now what? The thought of spending time in offices is beyond comprehension. I mean seriously, I am a medical device sales rep. The days of hanging around Operating Room (OR) lounges, walking from room to room, scrub sink cold calls and literally camping out all day in an (OR) are long gone. Instead, you have now have RepTrax, Vendormate, Vendor Clear and a host of other monitoring systems to keep an eye on you every time you arrive and depart their facility. Ouch! Awfully, difficult to cold call on the new surgeon who is busy and using the competitive product, isn’t it? This coupled with pricing pressures, competition, commoditization, compliance etc…. it certainly is not like the good ole days.
    I know that sounds harsh but if you really think about it for a few minutes, you know that I may be on to something. Now what? You can certainly hop from company to company hoping that one of them will be a home run if their stock price goes through the roof. I am not sure that is a viable strategy but HOPE can certainly cloud ones judgment. Do yourself a favor and buckle your seat belts because your ride is going to be a bumpy one unless you change. What’s next? Stay tuned!

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  168. I was with synthes for 19 yrs. YOU. ARE. WRONG. I could only get a few sentences deep in your post's as they immediately turned to name calling and ludicrous accusations.

    If you want to stay anonymous, that's your choice and a reflection of your [lack of] character- your posts on here are untrue and way out of line. You have no respect for this business. You guys tarnish everyone in this industry and it is a shame.

    Let me give you some advice- you are expendable. When the chips are down you will be dropped.

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  169. 8:09 You're funny!! As a rep for Mazor, I'm sorry to see that you've resorted to posting on here to try and promote your product. Sadly my earlier comments are dead on, and NO, I'm not worried about losing any business to the robot.

    As for your comment that "it's coming my friend, etc.",,, it should be hard for you to decide where go for surgery as there appear to be less than a whopping 12 units or so currently in use in the U.S.

    Intuitive Surgical they are not. Best of luck selling your next unit.

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  170. I hate to backtrack to an earlier Bacterin posting on a possible recall, but here is the info. Not sure how much is "spin", but considering the messenger, I wouldn't bet my paycheck on it

    http://www.faqs.org/sec-filings/110823/K-KITZ-INC_8-K/v233049_ex99-2.htm

    TSB --- possibly a little recon work and a new post?

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  171. Hey 2:37. I can envision you speaking in a French accent, sipping wine and smelling your own farts while you write your posts. Like the dude from Talledega Nights.

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  172. 6:17

    Shake~n~Bake!!

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  173. 5:37, thanks

    I heard the FBI made some arrests associated to the Bacterin recall. That makes me laugh at the term "quarantine" rather than recall. Maybe that's why they let Jesus and the other guy go...hard to do your job if they are rotting in the state penitentiary. :)

    Karma is a bitch!!!

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  174. 2:37 scary but accurate assessment of this world we now work in. there are so many 'me too' products out now that surgeons and hospitals don't see differentiation and therefore leverage us all over price. If you are with a large company that 'bundles' you have a leg up. Surgeons won't even consider fighting the tired old clinical resource nurses that insist they use contract only products bc of the kickbacks, I mean rebates, they get at the end of the year for being compliant. Reptrax, vendoclear, vendormate, colored scrubs (usually black) to designate 'rep'tiles...it sucks. Now these greedy spine surgeons want to not only collect their outrageous fees for performing surgeries, they want to collect distributor commissions for the implants they put in patients by owning distributorships! Thats on top of their consulting fees they collect from the companies they 'design' for.It's disgusting! Soon, there won't be any of us left and the surgeons will be standing around trying to figure out how to out-greed one another. Lord, help me find something else to do!

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  175. 6:19: That.Just.Happened!

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  176. Bacterin recall is right. "quarantine". Lmao

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  177. The following companies are jokes and their mere existence makes me howl in laughter:

    Wenzel Spine. are they led by Peter Pan?

    Spinal USA. their last website was the south central LA of cyberspace

    VG Innovations. didn't know a meathead WWE wannabe could be the CEO of a spine company. embarassing.

    Choice Spine. docs Choose to stay away.

    Phygen. *laugh out loud*

    Vertebration. who?

    More coming.

    That is all.

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  178. There have been no FBI arrests at Bacterin. The tissue was quarantined due to a market withdrawal, which is Classified as a minor violation. There is no risk to the patient, surgeon, or hospital, and the tissues are expected to be re released after an appropriate review process.

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  179. 12:49. Is that you Troy Taggert of Bacterin?? A surgeon just told me that he inked a deal with Bacterin. Shady Shady Shady.

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  180. I think the original post claimed 'associated with the recall'. That could mean anyone, including Bacterin (ie. Procurement agency, etc.). Regardless, bad things happen to bad people & the group in Montana have been playing dirty pool long enough, screwing over distributors that helped build their business, going behind their backs, buying docs left and right, etc etc etc. It's no wonder they hire reps out of that sales program in Colorado as it's only the newbies that aren't up to there cancerous culture and low brow antics.

    As one post said, karma is a bitch!

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  181. TSB - There you go again, posting anonymously to incite more BS on here. I not only have the proof you're doing it, I will bring forth that proof over the next few weeks. What started out as a decent forum to talk about the world of spine has no turned into nothing more than the opposite. It's not too late for you to correct it before you are definitively exposed.

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  182. 6:46 aka Chris Hanson

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  183. In the name of everything Holy, me we please have a new thread here?

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  184. When is Globus going pubic ?

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  185. I haven't read the Benzel article, but here are a few observations. The conclusion quoted in the post above said:

    "The data presented here strongly suggest that patients who attain stability (either by bony fusion or stable pseudarthrosis) have a much better clinical outcome than those patients who develop or continue to exhibit instability after a decompression via laminectomy for lumbar stenosis. Thus, in symptomatic spinal stenosis, uninstrumented facet fusion, along with decompressive laminectomy, offers the advantage of stabilizing the spine (via bony fusion or stable pseudarthrosis) without the extensive dissection and morbidity of dorsolateral fusion".

    So it could be extrapolated that using dowels to facilitate the stabilization (and they would inherently offer as much or more stability than packing autograft alone) could also lead to "much better" outcomes. Additionally, the surgeon could bill the same CPT code for both types of facet fusion, so that takes the "sham billing" effect out of the equation for dowel users. It certainly adds cost, but is it unreasonable to assume that some surgeons feel intuitively safer employing a technique that has some degree of standardization and reproducibility? As Benzel pointed out, achievement of fusion may be irrelevant since a stable pseudo offered similar benefit.

    It is puzzling, however, that no clinical data has been produced. If Benzel could achieve "much better" results with his technique, one would think similar results could be achieved with bone dowel type facet fusions. Maybe the dowel companies didn't think to compare their fusion results with a destabilizing laminectomy and were hesitant to compare the results to traditional, instrumented fusions. It would have been interesting to see Benzel's study include an arm of fusion patients with dowels.

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  186. I hear ZS is about to make a big move, and that Stryker is buying Globus...

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  187. Hopefully MM has decided to retire this blog. Good idea, it's run it's course. The concept was good, but flawed in the end. Total anonymity causes bad behaviour and misinformation, but using real names is just not practical. The only reason I have been reading it at all is to make sure that no one is slandering my interests. That gets real old. Good night and good luck, TSB.

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  188. This blog is great. As MM has stated many times, "if you don't like it don't visit the page". I agree we need a new topic here though... TSB, where are you?

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  189. 9:19 am

    Excellent points. First, the AMA specifically states that one cannot code for intrafacet implants (bone dowels) at the same level as the fusion. If the intrafacet dowels are used, then it has to be coded as a 0221T. Most insurance companies have stated in their policies that they will deny payment of that T-code as they consider it investigational and not medically necessary.

    Second, I believe the reason that there is very little info on the intrafacet implants is that I have heard that most of them loosen or migrate. So, any stability that they would have provided would be negated. Then, all one would be left with is a hole between the joint and very little chance of fusion.

    Lastly, if one can achieve good results by practicing the technique described I'm the Benzel study, then the additional cost of intrafacet implant to the procedure cannot be justified.

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  190. If Stryker buys Globus, does that mean Globus has gone public?

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  191. Bacterin didn't play ball with the spine reps, and they are all going to jail. The FBI is in the alley behind their building right now. Phygen? Dead! Spinal USA? Dead! Neidermeyer? DEAD! Who's with me??? (crickets chirping).

    Wise up. Just because a distribution strategy does not include you doesn't mean it is illegal. No matter how hard you wish, the OIG is not going to ride in on a white horse and restore your lost commissions. If you can't stand the heat, get outta the business.

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  192. The message: "The people's blog site where news, ideas, job opportunities and what's been heard on the street can be discussed in a professional manner."

    Is subliminal for:
    - WE DO NOT FORGIVE
    - WE DO NOT FORGET
    - EXPECT US
    ~ ANONYMOUS

    P.S. TSB Rules!

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  193. It just occurred to me that a popular blogger like TSB needs a 2nd in command in the event that he/she becomes incapacitated, dismembered, paralyzed or dies. Otherwise, we would never know of his/her demise and go on and on beating a dead horse to death again and again (like we are now!). Anyone know what the record is for comments?

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  194. 11:03,
    If the T code must be used and is not reimbursed, then is the sham billing allegation bogus? I have a feeling some docs ARE billing a fusion and not the T code. If a posterolateral fusion is performed in conjunction, can they bill the posterolateral fusion?

    Regarding the migration, I have personally seen many revisions of TruFuse and some of Nufix where the dowels migrated. There are some other companies that are used in my area, for quite some time now, and I have not seen or heard of those dowels migrating. So I don't know that migration issues are universal with all of the systems.

    Benzel didn't compare his method with dowels so we don't know that the results are equivalent. I read the abstract and the conclusion is that more stability results in "much better" outcomes regardless of preop isthmic mobility. If the dowels can offer more stability and reduce the amount of AP translation, they could outperform Benzels method.

    One would have to assume that these companies would try hard to prove that the dowels offer some additional stability compared to Benzels method and then use his study to promote that benefit. I have seen surgeons use the towel clip test to check for motion and they (dowels) do seem to reduce movement.

    Honestly, I was a bigger doubter of dowels BEFORE I read the Benzel abstract. Now I'm interested to see some test results for flexion/extension translation with and without dowels. Anybody got a sheep spine and some chiklets?

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  195. 2:14 The reason the spine seems more stable, right after insertion of bone dowels, is because the patient is lying on a table. When the patient stands, there is a whole different aspect of biomechanics that are in effect. Thus, the dowels migrate.

    Why use dowels when Benzel's study proves one does not need them? It's an extra cost that is not necessary. A lumbar brace is all that's necessary.

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  196. when is globus going public?

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  197. I like how all you reps know so damn much about dowels and stability and instabilities, etc. Why do we even need the surgeons? I think you all should be promoted to Rep, MD.

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  198. 1:15,

    That was really funny!

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