Tuesday, March 29, 2011

Cervical Arthroplasty: The Future is Now

As start-up and early growth stage companies continue to build their portfolios on "me too" technologies, TSB envisions a day where a large percentage of cervical procedures will give way to cervical arthroplasty.  No fellow bloggers, fusion is not going to go away, so don't panic and throw your cervical plates, inter-body devices and biologics away.  But if I were running your companies, I would place a greater emphasis on cervical arthroplasty, and quick, like yesterday.  If there ever was a segment of the spinal column that lends itself to this device, the C-Spine is where its at.

Most of you would agree that key features in a disc design is the center of rotation, the stability of the product and the material used.  We're just beginning to capture the retrospective data in a manner that provides surgeons with the clarity necessary to make these procedures successful. Over the years we have been introduced to metal-on-metal, ceramic-on-ceramic, metal-on-poly, poly-on-poly, and ceramic-on-poly.  Legitimate arguments can be made as to the pro's and con's of each design.

So the question must be asked of our readers, what is the optimal design? In terms of motion, cervical discs can be classified as unconstrained, constrained, semi-constrained, and disc that mimic movement.  Yet, questions still remain as to the effect this procedure has on disc height and facet joints.  Time and retrospective data is providing the industry with a better understanding of how altering the natural biomechanics of the spine can result in success and or failures of these procedures.  As much as we have learned in the 45 years since the first disc was created and implanted, there is still work to be done.

Unconstrained devices allow for translation which theoretically mimics normal motion, yet may increase shear and torsional loads on the facets. In addition, a greater emphasis is placed on surround soft tissues and the PLL for stability.  Constrained devices are known to minimize loads through the facets but have a fixed axis and required accurate placement.  How many of our bloggers marvel at the claims that many of the players in this arena have made regarding their devices.  Some have called it first gen, some called it second gen, some claimed in was third gen, all without any long-term retrospective data.  The industry was bombarded with marketing at its best, or its worst.  

We have been told that some materials provide better wear resistance (ceramics), some have a higher wear rate but low stiffness (polymers), we've been exposed to keels, teeth, and coatings, yet, the critical feature is the device's axis of rotation and whether it matches the physiological center of rotation.  The challenge is identifying the center of rotation on a level by level basis.  So who has the optimal design?

Is it the Synthes ProDisc C,  is it LDR's Mobi-C, is it Spinal Motion's Kineflex-C,  is it Globus' Secure-C, is it Stykers metal-on-metal CerviCore-C,  is it NuVa's CerPass, is it Medtronic's Prestige,  these are just a few of the prominent players in the market, in addition how big will this market truly be?  When one analyzes the analysts forecasts, one can only shake one's head in amazement.  Some have estimated that this will be a $400-$500 million dollar, but those people are smoking something that many of us have never smoked, or at least you didn't inhale.  Contrary to popular opinion, TSB sees this at max as a $200 million dollar marketplace, as long as the insurance industry and the government don't "fubar" this procedure.  In addition, this is a young person's procedure, (sorry grandma), especially at these prices.  So in the spirit of debate, who has the best design, how big will this market truly be, and is this a procedure for one or for all?  TSB wants to know what our bloggers think?


44 comments:

  1. TSB, what are you smoking? Listing all of those "Me-Too" discs in the same sentence at the PDC... I'd argue that Synthes has 90 percent of that market, easily. And its not going anywhere - they have the best cervical arthroplasty training infrastructure out there. The most thought leading surgeons involved in implanting, evaluating, and modifying the device and technique. And, they are the "Kleenex" of cervical arthroplasty - the other companies come to a surgeon's mind only if they are offering an IDE or a consulting agreement (or both).

    ReplyDelete
  2. This market has very limited upside for two reasons:
    1. Surgeon reimbursement is less for a cervical disc than an ACDF.
    2. Major regional payors such as Anthem BCBS in Ohio, Kentucky and Indiana do not cover it.

    Both of these dynamics need to change in order for this market to grow long term.

    ReplyDelete
  3. 6:02 Congrats on dominating a tiny, overhyped market that makes up less than 1% of all spinal implant sales dollars.

    By the way, I use Kleenex to wipe my bottom....it's softer!

    ReplyDelete
  4. As TSB loves to say, Syntes got taken to the bank by the VBrothers, even they marveled at how much they got for the disc, Wyss keep Orsinger, a pharma guy at the helm, you're definitely going places, like Waldo. That company is a mere shadow of what it once was.

    ReplyDelete
  5. How this market place develops is dependent on two major factors
    1. How the CDR compares to ACDF clinically
    2. whether the reimbursement environment changes - particularly will it become less biased towards ACDF if the results of 1. are pro CDR?

    Current data appears to be suggesting that CDR is at least comparable, from a clinical efficacy perspective, to fusion and my be more cost effective (see http://www.orthosupersite.com/view.aspx?rid=81941). Will data such as this convince payors to revisit their reimbursement policies - maybe but it will certainly take time.

    Assuming that the reimbursement environment becomes more positive, the ASP for the discs comes down to $3k, and 25% of current fusion procedures convert to disc replacement this would give a potential market of approx $150M (in US).

    ReplyDelete
  6. Seminars in Spine Surgery, Vol 23, No 1, March 2011. Page 77. "On the basis of these data, the authors conclude that total disk arthroplasty is equivalent to ACDF for providing relief from symptoms in the treatment of 1 and 2 -level degenerative disk disease of the cervical spine." BUT HERE'S THE KICKER "The risk of developing adjacent segment degenerative disease is equivalent after both procedures, but is significantly greater in patients with concurrent degenerative disease in the lumbar spine."

    Call me stupid, but a lot of money has been invested and spent with what I thought was supposed to reduce adjacent segment degeneration. If it is no better, and insurers are balking at paying, why all the hype?

    ReplyDelete
  7. 6:22am, you are a fool. prodisc c is the only innovative technology in the entire industry (innovative defined as a technology with long term clinical data as well as minimal competition) today and synthes reps can talk about it at the hospital daily and also try to sell their other shit. prodisc worked out great for synthes. Let everyone else keep dying by buying nothing and hawking their commodities. it will be funny a year from today when 75% of management teams are axed for being conservative to the point of being unnecessary.

    ReplyDelete
  8. Sounds like some of you are more interested in pumping up your company rather than talking about the pro's and con's of cervical arthroplasty, as usual, its amazing that some of you aren't under physician's care for ADD. Stick to the subject, don't spend so much time selling your company, or is that too difficult to do? So why is your device better? Because you have more cases? Because you have the optimal design? Just because you're one of the first to market doesn't mean yours is the best, it only means you have more experience.

    ReplyDelete
  9. 7:48
    Prodisc c is a very innovative fusion device.
    Just because it has longterm clinical data doesn't mean it's good data. Look at the rate of HO in the pilot study itself... The real world experiences I have seen are even worse.

    ReplyDelete
  10. Sorry for the newbie question, but don't all devices ultimately wear out? If so, how do any of them compare in their long-term efficacy and safety versus a biologics solution, assuming one had non-ectopic bone growth in the cervical area (unlike Infuse)?

    ReplyDelete
  11. Off topic, but I hope no one has done business with this guy:

    http://online.wsj.com/article/SB10001424052748703858404576214642193925996.html

    ReplyDelete
  12. please look at the us ide results. if you look at the range of motion prodisc FAR exceeded acdf. If you look at all the other results prodisc was comparable or better significantly.

    with that said you are correct that there is Heterotopic ossification. however, you shouldnt use the word "worse" if fusion is a good thing. Since fusion is obviously a good thing since it is the standard of care then having HO a specific amount of time is not the worst thing. Yes, personally i would ask for bone wax to be applied so i dont have the chance for HO.

    Regardless the clinical results speak for themselves.

    ReplyDelete
  13. What is the status of each C-disc? Some of them seem to be lost in a clincical trial, though I wonder if the companies are really working to push them thru the FDA.

    ReplyDelete
  14. At one time they fused knees as well.

    Just because you sell more or think you have more market share does not make your device better, nor does it make fusion better.

    ReplyDelete
  15. The ultimate success or failure of the procedure, and the individual devices, will rightfully come down to the short and long-term EVIDENCE. Cervical disc already has more Level I evidence supporting its safe and effective use than essentially all other spine technologies, and the best medical evidence for ACDF has actually come from the cervical disc control groups. Look at the evidence carefully as it continues to grow with the 5yr data becoming available for several devices and initial 2yr data coming forward for numberous others. (For those that may have attended CSRS and/or Joint Section) There is one consistent message: cervical disc is at least as safe and effective, and potentially superior to ACDF. The depth and breadth of the data is becoming decidedly favorable in support of C-disc.

    ReplyDelete
  16. In real encounters every day I run into the following hurdles with CDR.

    1. Surgeons will tell you that ACDF's are their best procedure, patients typically always do well. (granted, some come back with adjacent level disease but I think thats a bonus of sorts for these guys)

    2. Insurance has not embraced CDR yet, it gets better everyday but its still difficult to get approvals and some physicians arent comfortable telling their patients that they MAY get a CDR if insurance approves it, if not the old reliable ACDF.

    3. Insufficient published data showing significantly decreased adjacent level disease as compared to ACDF.

    The cost I have not found to be an issue as the price of a one level CDR can be pretty comparable to 1 level ACDF with bone graft if you get aggressive. Technique is not an issue either, really it just comes down to the above 3 things. So I guess my take is that if Insurance goes all in, and studies are favorable then this will become a hot surgery for your standard 1 and 2 level cervical disc patients that are below 40 years of age.

    ReplyDelete
  17. Anyone hear any rumors that Orthofix is trying to acquire Nuvasive?

    ReplyDelete
  18. I have not heard that ^^^

    ReplyDelete
  19. That would be another dopey move by Orthofix.

    ReplyDelete
  20. 6 year data....No differnece ( ie. NOT superior) in adjacent level disease, the reason TDR was developed and pushed as a better product

    2011.... ACDF re-inbursement reduced to the same RVU as disc arthroplasty so now your asking a surgeon to put in something and an insurance company to cover the cost of something that pays the same, but costs twice as much...good luck!

    ReplyDelete
  21. LDR is a joke. Company has no idea how to sell a motion preservation device. They are still trying to figure out how to safely revise the ROI-A and ROI-C. According to a surgeon I spoke with, the only revision strategy is a corpectomy. They will be bought for pennies on the dollar in two years as every company now has superior zero profile technolgy.

    ReplyDelete
  22. 5:33

    You obvioulsy have no idea what you are talking about. LDR is an inovative company where revision is very simple. Sounds like the ldr rep in your area is kicking your screw based stand alones' ass. I am a legacy distributor and we cary ldr and these guys truly are ligit. And as far as motion preservation, i promise they will be market leaders with the mobi c. The data they have will speak for itself especially for multi level. no need to reply my friend... the future will verify my statements.

    ReplyDelete
  23. We've heard this tune before in 2004. Good fusion is better than bad motion...

    ReplyDelete
  24. 6:05 - i must reply. Ligit indeed.

    ReplyDelete
  25. 6:47. Don't know about mobi-c, but have sold 9 roi-a's to 3 different surgeons and two had to already be revised due to the sacrum being spliced. The plates acted like osteotomes.

    ReplyDelete
  26. 6:05. This makes no sense "....is an inovative company where revision is very simple"....but I am curious how the Depuy sales are going.

    That said, the ldr guy in my territory is doing better than expected. While revision may be a pain in the ass, I can't really buy into selling something as "being easier to revise".

    ReplyDelete
  27. Boys and girls, CDR is here and it will stay. So far no-one has come out in print that they are seeing less adjacent issues, but it's coming. Why, because there is a significant learning curve to get it right and enough are now getting it right that we will see improved result, yes better than fusion particularly at the adjacent levels. It takes a lot of practice and forethought to get it right based on the design used. There will come a time that the easiest to do and competitively priced will likely take a significant share. Unfortunately, there are those that use these systems and assume, just because they got it in there, the patient will benefit, but truth is until there is a freaking robot to place the thing in the proper place so it can work as designed, there will continue to be less than desired results. It's also not entirely their fault. Everyone assumes the COR is easy to find and hit with the implant, but folks, this just ain't so. And, being off a just a little at one level affects the adjacent levels adversely. The issue is not neccessarily which one is right, or which technology is right, but that the device is put in EXACTLY as designed. And that's no small task.

    If there is an opportunity to push this and other non-fusion technologies further, it is my opinion, and take that for what it's worth, it will require someone to take on a serious and significant patient advocacy roll. It's happening some in NC where patients are being denied care, but it's a push by the docs to get their patients to bitch to BCBS. It's not a good grass roots effort. Any takers for this less than desirable, certainly no opportunity for income or grantitude roll?

    ReplyDelete
  28. 7:32 Hit the nail on the head. Tough to remove a "fish hook" without some destruction of surrounding bone/tissue. Real issue with ldr is that most distributors will be forced to drop the line now that every company has superior technology. By the way does the term Legacy have any significance? I'm impressed.

    ReplyDelete
  29. my grandmother drove a tan subaru LEGACY in 1983. does that count for something? im feeling really important and i think that makes me legit too. im so wise and i love hearing myself talk. Here comes the name calling and spell checkers.

    ReplyDelete
  30. If the last 10 years has taught us anything it is that fusion will always be the gold standard.

    ReplyDelete
  31. 4:43. For starters I personally have removed the LDR cervical stand alone and it was rather simple. Let's face it were not talking about a cemented hip stem fpr gods sake.

    That being said what would you rather have left after removal, 2 "slits" in the endplate or screw holes and need a corpectpmy.

    By the way, I love watching the medtronic monkey rep leave the locker room cause I took his plate case! What a corporate dildo those guys are!

    ReplyDelete
  32. 5:36....How have you "personally" removed if your a rep?? Also are you saying that in order to revise a plate (with screws) you will need to do a corpectomy? Just curious.

    ReplyDelete
  33. 5:27 - "If the last 100 years have taught us anything, it's that gasoline automobiles are the gold standard." Sincerely, Nissan Leaf, Toyota Prius, Chevy Volt, etc.

    ReplyDelete
  34. Was referring to other stand alones which are a screw system.

    ReplyDelete
  35. 5:36
    Those dildos? Not that I am a big fan of MDT but you sound like such a tool you should be working there. Arrogant and uninformed. Do you realize what 6:39 was saying to you? Renob!

    ReplyDelete
  36. When I buy a piece of furniture I want mine to have dovetails, screws, and glue. You know quality. ROI is simply stapled and glued.

    Send it back to France!

    ReplyDelete
  37. 4:46

    Actually, I heard NuVa was in the market to make an acquisition.

    ReplyDelete
  38. NUVA is going to need to buy something to look like a growth engine again ... problem is it has to be mostly a stock deal (they don't have the cash), and that will create problems on who they're going to be able to get. The stock is their currency, and you're either a growth story or an earnings story. Right now, they're neither.

    ReplyDelete
  39. Can XSpine continue with current sales model without imploding? In a hospital yesterday in California and talked to the purchasing manager 3 separate distributorships with different prices selling the same plate? How can this be good business?

    ReplyDelete
  40. 3:20 - Take the lowest one....? That is a mess. What specific plate/system are you refering to?

    ReplyDelete
  41. All above, check your facts. LDR just submitted a 26 million $ PMA that finally proves to a P factor of .00000001 (is that statistically significant enough for you?) that 2-lvl arthroplasty is superior to fusion. This will lift all boats, but LDR will be surfing with that 2-lvl indication. The Medtronic homos are not far behind.

    ReplyDelete
  42. Did you heard what Rob Matts said about that?

    generic nolvadex

    ReplyDelete
  43. Interesting theme admin & I am unnecessarily lively for your data through this site, I may in like course need to give data identified with Cervical Degenerative Disc. For additional edification please visit http://www.erikbendiksmd.com/

    ReplyDelete