Tuesday, December 6, 2011

NEIN X NINE = NEIN

No spine nation, it's not the Godfather of Soul (may he rest in peace),  neither is it that other Godfather, you know the one that ran a pizza  company who basically was taken to the woodshed by his wife Gloria last weekend, neither is it memories of Adolf Hitler who liked to scream, "Nein, Nein, Nein."  What Nein X Nine =  Nein  amounts to is the answer that the Supreme Court issued to Blackstone Medical and Orthofix with regard to their Petition for a Writ of Certiorari.  The Cert Petition is a legal request to the SCOTUS whereby a defendant, in this case Blackstone and Orthofix, asks the Court to review a decision by the a lower court, in this case, Blackstone Medical Incorporated v. U.S. ex rel. Hutcheson.  But before we go any further let's understand the issue at hand.

The issue in Blackstone Medical was whether a device company THAT PAID ILLEGAL KICKBACKS to prescribing physicians (we know who you are) could be liable under the False Claims Act for causing false claims to be submitted to MEDICARE.  The basis for the law is that anyone submitting claims for federal monies cannot submit false or fraudulent claims.  If so, the Federalis can recover large fines for each submission as well as treble damages.  Treble damages is a term that indicates that a Statute permits a court to triple the amount of the actual/compensatory damages (are you listening boys).  In addition to the treble damages, the whistleblower shares in the bounty.  Blackstone, Orthofix and its cadre of attorneys were hoping to argue that another law for which the filer had certified compliance was being violated.

Considering that this Writ of Cert came in front of the Robert's Court and was denied is BIG.  It seems that Blackstone's/Orthofix attorneys were hoping for a "Hail Mary"considering that the Roberts Court has decided five FCA cases in five terms.  In addition, for those that applauded the effort of the Writ and the law firm for throwing the kitchen sink at the plaintiff, let us remember a few facts.

            It is estimated that the SCOTUS usually hears 40-50 cases per term
            Legally, 99% of the time, a Writ like the one filed by Blackstone/Orthofix is denied

Why? Because the SCOTUS adjudicates issues that affect and effect Constitutional Law or disputes between Circuit Courts of Appeals with the intent to create uniformity in the law.  So the question is asked, will this establish a new precedent, whereby any company that knowingly and willfully is involved in kickbacks (PODS?)  think twice about its business model?   Will the BOYZ and Orthofix be ready to ante up more than that $50 million in escrow that has been reserved for this rainy day?  Or, will their arrogance and money let them believe that they could crush the whistleblower acting like the two thousand pound gorilla that they like to think they are?  The end result is that not even Darth Vader will right the ship.  So like TSB likes to say, "it's game time BOYZ."  This is an opportunity for the DOJ to set an example once and for all.  Stop acting like the paper lion that you are perceived to be by those of us in the industry that attempt to do the right thing.  Bitch slap the parties involved with the MAXIMUM, don't negotiate.  Let them come to you asking for forgiveness and show them no mercy. Considering that they thumbed their noses at everyone, pay back can be a bitch.  So you know what Jackson Browne use to sing;

I'm sitting down by the highway, down by the highway side
Everybody's going somewhere, riding just as fast as they can ride
I guess they have a lot to do, before they can rest assured
Their lives are justified, pray to God for me baby, He can let me slide

Cause I've been up and down this highway, far as my eyes can see
No matter how fast I run, I can never seem to get away from me
No matter where I am, I can't help feeling I'm just a day away from where I want to be
Now I'm running home baby, like a river to the see.

Seems like Blackstone and Orthofix have them Bright Baby Blues.  Who knows, maybe OTW will write something in defense of the industry?  The bigger question that remains is whether or when will the government proceed with criminal charges?

120 comments:

  1. Wow! Would u distribute their products?

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  2. Like I've said in past comments, I've been hearing that someone will be getting their tit in the ringer for this stuff for over 12 years now. I have yet to see any indication that the DOJ takes this stuff seriously. I predict that it will be nothing more than a slap on the wrist and business as usual for the cads at orthofix. This is a layup that even the DOJ can't miss. The question is, do they have the will to act ?

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  3. Usually the government waits for the civil action to be decided prior to taking criminal actions, the question remains will the DOJ slap them with a large enough fine to send a message to the industry and deter all the shenanigans that go on, or, will it be business as usual. As TSB stated this is there chance to set a precedent. Will they or won't they, that is the $65 million dollar question.

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  4. What about the surgeons involved in this mess?

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  5. Interesting comment to the role this law may have on an legal action on PODs. We are on this one. Take the escrow money and lets get to business on the bigger problems.

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  6. TSB do you think it's time for some surgeons to lawyer up?

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  7. I am seeing Orthofix in my area paying surgeons with all kinds of "consulting" agreements and pushing their pedicle screws and perc screws. Are they legit or is this all pay for play shadyness?

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  8. Anything can be made to look legit. Just ask your local Danek rep.

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  9. Yea, but based on the appellate courts decision looks like Blackstone and Ortho-Fix are perfect for one another. Can you say I'll offer you a little more in a settlement in exchange for acknowledging no wrong doing?

    NEIN, NEIN, NEIN = DOJ please rip a sheet out of B'stones and Ortho-Fix ASS

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  10. "People in glass houses should not throw stones.". Our whole industry has had a spotty track record of ethics for a while. Medtronic's issues have been well documented. Big five ortho already went through DOJ fines for their recon divisions, and I promise that if their spine divisions had been scrutinized you would have seen even more problems. So far that puts Medtronic, Depuy, Stryker, Zimmer, and Biomet in a position where they can't pass judgement on anyone. Now let's talk Nuvasive, Alphatec and Globus - is there anyone selling spine who really believes there are no skeletons in their closet. Add in many of the small companies who have questionable business models and you pretty much have accounted for the entire spine industry.
    Keep in mind that I'm not saying that most of us aren't honorable reps who do things by the book. What I'm saying is that every company has or had questionable business dealings. Blackstone may have been worse than some back in the day, but primarily, they got caught and the length of the litigation keeps the story in the news.

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  11. "Bright Baby Blues"? I suggest it's more like 'The Fuse" or "Running on Empty". MSM-love the JB quotes.

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  12. 6:18
    Me thinks you doth protest to much!

    Do you drive a Bentley by chance?

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  13. burn baby burn, you better run faster then my bullet, you better run faster then my Gun, with your pumped up kicks($$$) any doc who is involved in pod's or shady consulting agreements need their payback,
    Signed your truly unaware patients

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  14. I remember about four years ago calling on an "physician participant" agency in S. Texas and watching the principal thrust out his belly, rap his desk top and hear him brag on how Blackstone was laying $25K large right on it every three months. I agreed with him that was a high level of "customer support".

    It was only just the start of this industry's downward slide.

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  15. Did anyone catch this article in Forbes:

    http://www.forbes.com/sites/larryhusten/2011/12/04/cms-tightening-the-screws-on-unnecessary-procedures-in-florida-and-10-other-states/

    Looks like CMS will be heavily scrutinizing spinal procedures in the near future. Those surgeons in the business of instrumenting everyone who walks in the door are in for a wake up call.

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  16. That's certainly significant. What's largely left out is the question of how the criteria for payment will be determined. Who and how do they decide that a procedure is unnecessary?

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  17. Actually the scuttlebutt was that everything was based on procedural volume. Let's make a spreadsheet, place the surgeons name next to it and then scroll the word volume next to the surgeons names. 100 surgeons / 5 projects = 20 consultants for each project. Sounds like an Olympus deal to me. Orthofix must have bought the best portfolio the industry had to offer, LMAO SUCKERS

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  18. Does this mean Stromer loses another "consultancy" opportunity?

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  19. Spot on 6:18. I love the way the big companies (Medtronic, Depuy, Synthes ) are so above board now. MDT was built on consulting agreements and sham royalty deals. Is Dr. Foley's IP really worth $20 million per year. I would hate to be a 7% rep for one of the big boys right now. POD's are growing like weeds and the ankle biters are hiring surgeon's girlfriend's , derelict children and paying 30 points.

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  20. big blue zimmer, on its way to #1

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  21. 9.55am what planet do you live on. Zimmer do not have a clue about spine. Look at their Abbott spine acquisition. $330M combined sales now down to just over $210M and having managed to piss off everyone they dealt with. They only care about recon. If you work for Zimmer just be prepared that when you leave they will hire private investigators to follow you and then drag you through the courts!

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  22. 9:04 you're a douche bag. Would it make sense to pay a surgeon $20 million for his business? Did you even finish 8th grade math? How the fuck would that make any sense? How much business can a surgeon generate to make 20 million payoff. And BTW if he developed an Apple App and made 50 million people would aplaud.

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  23. Such admirable professionalism on here, a lot of you act like you're in 8th grade. Clean it up ladies and gentlemen and quit making us all look bad!

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  24. well put 9:04. I work for one of the big boys making single digit points - wondering what I'm doing.

    who has solid statistics as to what percentage of procedures can be instrumented with a very basic bag of hardware. all the fancy new trinkets are great but I would take all the 1-3 fusions I can get at 30 points and call it good.

    a cervical plate, bone screws, pedicle screws, a few peek options, rods, set screws, etc and you are good.

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  25. to 2:58pm and all like him.....

    Come join us. We can get the products you ask for and all manufactured in the US of A. How many want to line up? Your surgeons can play too! Not the POD way. That won't survive. Your hospitals will love what you have. For those wanting to hear more, let us know how to contact YOU.

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  26. Sorry, but as course as he/she is, 11:49 hit it right on the money. Right now the big players are cleaner than most, hence their losing share to the ankle biters still providing pay for play opportunities.

    Foley and others of the ilk made significant contributions (Stealth, MED, MERI just to name a few) that while their value was undetermined at the time, turned out to be goldmines that their contracts pay them handsomely for. That's not buying business. Someone cashing in only six or five figures for nothing other than sending business someone's way is far more dispicable.

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  27. ... oh, and some of you seem to need to be reminded that single digits of a whole lot trumps thirty percent of nothing any day of the week!

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  28. Any insight on companies like Si-Bone? Solid start up or waste of time?

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  29. If anyone is wondering why spine is under scrutiny, check out the latest healthcare utilization report at:

    http://www.hcup-us.ahrq.gov/reports/statbriefs/sb123.pdf

    Costs for inpatient spine surgery in non-elderly patients have gone up from 2.5 Billion in 1997 to 6.6 Billion in 2009. But notably, the cost increase lies not with more procedures, but with a much greater cost per day (procedure), as the number of inpatient procedures remained constant at 1.6 per thousand in both years. As you can see in Figure 2, none of the other high growth - high dollar categories had such a high percentage contributed by cost per procedure.

    Friends, that's why we have such a big target on our backs. For the price we're charging society, we'd better be delivering better outcomes with our technology and services.

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  30. Si-Bone, toughest sale I ever tried to make. The spatial gymnastics required with two c arms trying to correctly place the implants is damn difficult and lengthy. Not sure if worth the effort.

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  31. 3:24, I want to talk.

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  32. 3:24-I'd like to hear more too. Do you have a twitter account?

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  33. @737 ... Interesting ... Thought it would be an easy straightforward procedure. Thanks for the insight

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  34. Question to anyone with knowledge of healthcare laws. Hypothetical---Say there is a hospital system that has blocked out all vendors except 2 or 3 companies. The surgeons were allowed to hand pick the companies .
    some of the surgeons , not all, have in the past been paid consultancy fees and royalties. Is this quid pro quo? Is this ethical? Is there a violation of federal anti-kickback laws and medicare laws. since this would be a "closed" system where bidding did not take place but paid consultants influenced the "monopoly." Would materials management administration also be legally liable for going along with this? Just wondering, not to say that is the case anywhere but would there be laws broken by the health care system? Would the representatives and management from the company also be legally liable for making these backroom deals? Just wondering if company lawyers look at these contracts and due diligence of conflicts with money paid out in past 7-10 years to surgeons.? Just a hypothecical situation....

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  35. Hey 7:10

    Dude, just move on. Life is short. Stop pounding your head against the wall. I assume you're a sales guy and not a lawyer. Keep your head up!

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  36. Foley wouldn't generate 20mil if he operated 365 days a year.

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  37. 3:24, shoot me a message at lumbarlarry@gmail.com

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  38. 7:10am.....Hypothetical?! It's called HCA!

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

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  40. 7:21 isnt this a blog? isnt this where we are supposed to inquire, post and ponder? or would you rather read the same peoples comments on Globus going public, Depuy going direct, or PODs?
    just looking for answers from those in the know

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  41. Jesus! listening to some of these conversation on this Blog are absolutely mind numbing!!! TSB can we please make rules to this blog? charge a fee to get on the site if you have to, and hire an administrator to delete all the crap people post. You got some moron like 9:55 says Zimmer of all shit spine companies is gonna be #1, you got this dope 3:24 reaching out to people to sell a line that will make "hospitals love you", and of course we always get the one moron asking if Globus is going public. There is so much out their to discuss, and we waste time listening to half these people who have been reps for 5 minutes. Lets talk real spine.

    P.O.D: Illegal or Legal? if Illegal who will make the move to stop them? if legal why hasn't this model carried over to joints and other divisions?

    whats the future gonna hold? If technology is gonna plane off, and hospitals are going to determine pricing, whats next? Service? added benefits? will there be a mass layoff like there was in pharma? less reps, more territory?

    Whats going to happen to NUVA? Does Medtronic acquire them?

    Orthofix/Blackstone: does anyone get locked up? do all paid surgeons get exposed?

    Infuse: Class action suits coming? does it cause cancer?

    small companies? who's the next to fold there tent and call it a day?

    acquistions: whats the most tempting buy? why? and for who?

    Cost: will we see PEEK disappear and go back to Bone?

    lets get something going here with some real facts.

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  42. PEEK interbody can't dissappear: let's recall why it's here :
    There just isn't enough donor bone of high enough quality to be able to supply all the machined wedges needed for both cervical and lumbar.

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  43. 3:45
    Dude, relax. You don't have to read every post.
    You have some good questions but just like in real life you'll have to sort through lots of information before you can make a call. But if it makes you feel better I will answer all of your questions:

    1)POD = Illegal. Looks, walks, quacks...etc.

    2)Commission cuts. Solves most concerns.

    3)MDT acquires NUVA after bleeding them.

    4)Orthofix/Blackstone = Someone is going to jail but it will NOT be a surgeon.

    5)INFUSE = Yes and Yes. $1B+ but they have already banked the cash

    6)Too long a list. The fall will be like a cascade so just hope you get picked off by one you can stomach.

    7)Zimmer buys Lanx b/c they still can't figure it out. Stryker sucks it up one more time for Globust. MDT gets NuVa on the cheap since they already own them.

    8)PEEK v Bone? Think Ti my friend!

    Real Facts? Try the WSJ.

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  44. @3:45

    Joints ARE being sold heavily through POD's

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  45. 6:20...
    1) wishful thinking
    2) sux for bigs but easier for smalls
    3) both losers like you
    4) do not count on it
    5) one thing you could be right in regards
    6) more survive than those that die
    7) both deserve each other so who cares
    8) lmao
    9) real fact...you have too much time on your hand where you need to be selling

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  46. 8:24
    Yes, they have too much time, unlike you.

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  47. ....and one more question: when is Hans Joerg Wyss going to jail?

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  48. Dear 620,

    You should have posted at 420, that would be reflective of what you are smoking! Zimmer buy Lanx???? It'll take at least another 2 years for the Minneapolis crew to suck every last dollar out Lanx

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  49. The reason joints aren't through PODs is because unlike a simple screw, a joint is a complex articulation dependent on reliable technology. Their job is function. ours is fusion. fusions isn't so complicated...

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  50. Joints are part of PODS. Put 5 femoral components in front of a surgeon 5 feet away and they will not be able to tell you who makes it. There is no technology in joints.

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  51. Quote of the day, from 1:00pm: "fusions isn't so complicated..."

    Nice!

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  52. 1:22

    the scientific merit and lifespan of a total joint isn't a beauty contest done @ 5 feet. Its the choice of metal, proprietary method of cross-linking the poly. Exactech/Omni knee's last 5-7 years. Zimmer/Depuy/Stryker/S&N/yougetthepoint last 12+

    Of course every patient is different. Lifestyle, BMI and success in PT make a huge difference in both post-op function and long term joint success. At the end of the day, i'd let you use most any type of screw on me that has passed the FDA pull out parameters. But at the same time, I wouldn't have anything but a press-fit Zimmer knee in me.

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  53. 1:00PM
    Your statement makes me want to move to your territory so I can compete against a moron. How many articulating surfaces for a vertebral segment in the lumbar spine are there? The answer is 3. The uncovertebral joint and the two facet joints. The spine is a far more complex system of joints than a total hip or total knee. Each of those procedures are performed in as little as 30 minutes skin-to-skin. Here's a factoid about joint replacements. Over the last 20 years there has been no major break through in material or a paradigm shift in design. Please don't waste my time talking about cross-linked polymers - we did that shit in the early 90's and then DePuy gave us Hylamer ( what a blast). Don't say metal-on-metal because that was tried in the 70's only to have the PD geniuses forget and reintroduce in the early 2000's. By the way, how's that working out for DePuy?

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  54. MN crew sucking every dollar out of Lanx? I don't understand, please elaborate. Is there a ZS arrangement with Lanx already?

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  55. It's not the implants you imbeciles. It's the surgeon. A good surgeon can use just about any system to implant into a patient and have a good outcome. Surgeons use systems that are serviced by individuals they can trust and rely upon. There are rare exceptions where a device is a leap in technology and there's nothing else like it in the market. Spend more time developing yourselves to be the most educated medical device rep around and be an asset to you surgeons and hospital customers. After all, if it really is only about who has the shiniest implant, where does that leave you? Would you like fries with that...?
    J

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  56. Back to SI Bone. Is this company legit or a flash in the pan? Does the technology help patients or is it snake oil?

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  57. Who kmows, 3:50? Something is up. CEO Gladneys track record shows he comes in and fixes what he can and sells. Only problem is that Lanx is so dysfunctiional not even he can fix that one

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  58. SI bone, and Wright Med...same pig different lipstick. That answer your question?

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  59. Maybe SI Bone will buy Alphatec. Stock closed at $1.61 today. And I thought it couldn't go any lower. I guess the stock price is in a race to the basement along with their management. :)

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  60. No way SI could by Alphawreck. They are pouring all their money into a direct sales force.

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  61. 5:50 PM, I heard SI bone would be bigger if it weren't for the pig you speak of.

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  62. You guys are clueless on POD's!

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  63. Now there we go. 6:42am comment has really imparted great wisdom. We would be lost without this comment?

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  64. So I suppose the sharp increase in surgical denials on the private (insurance) side coupled with the new CMS policy to "review before payment" which is designed to "prevent unnecessary procedures" for Medicare is not important information that warrants a real discussion. You guys really don't get it....smh

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  65. Please clue us in on PODS. In fact, tell us where your POD is, who participates and what the model is. Come on out in the open if it is so great, legal, ethical and morale.

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  66. No way, Jim Pastena says its a legitimate company, LMAO

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  67. Do facets articulate after they are removed during a TLIF? Just curious.

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  68. When a surgeon TLIFs it is typically performed unilaterally, thus leaving one facet joint intact. If your surgeon PLIFs then both facets will be left intact. There are now techniques where a surgeon can perform a discectomy and insert an IBD obliquely and never touch the facets.
    I agree with Dec 9, 3:49PM. Over the last 20 years technology and technique have lead spine surgery and implant development. Some have been home runs while others have had disastrous outcomes (ie. the good - poly screws, complex deformity corrections, total disc replacement and yes even the XLIF procedure). The only real innovation in total joint replacements is the anterior total hip approach and the use of imaging studies to drive robotic guided milling. Total joints still use Titanium, CoCr, UMWPE or Ceramics and the approaches and implants look just like they did 25 years ago with the exception of the anterior approach for hips. Let's give credit where it's due though, total joints are a much more mature surgical segment of the medical industry having decades of development efforts to get where they are now. They have also done a much better job of collecting outcomes data to help show the efficacy of their implants with expected success rates and longevity.

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  69. @5:35AM
    Nice post, but how does one address the pathology of far lateral foraminal stenosis in your TLIF example? My suggestion is to use iO-Flex from Baxano to do a contralateral formainal decompression to ensure that the foramen is thoroughly decompressed. Doing so in this fashion provides a solid decompression w/ mininal disruption to the facet joint.

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  70. 12:25PM
    My post was in response to fusions. A surgeon would only use a PLIF or TLIF procedure in the presence of instability where fusion would be necessary to stabilize the affected segment.
    The iO-Flex is certainly a viable option to perform a decompression without the need to fuse. I could also see a place for the iO-Flex as an addition to MIS Pedicle screw placement providing a surgeon the ability to still decompress without doing an open procedure. Good post that makes my point - spine is continually innovating providing surgeons with techniques and devices to better treat their patients. Our industries' responsibility should be doing a better job collecting data to provide evidence based care. Every company out there should have their rear ends spanked for not investing more in outcomes data.

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  71. 12:45 Just to clarify, iO-Flex can be used w/ or without fusion. In the example above, it works very well in providing a contralateral decompression in a TLIF. It also works extremely well in adjacent level scenarios where only 1 level has instability, but the adjacent level is stenosed. As for your comment re: MIS screws, iO-Flex in not used in a perc fashion, but in open, mini-open or tube based procedures.

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  72. @1:03..thanks Tony! now, when are you hiring Roger to ensure that you add more "deformity" to your management team, what with Joe "shortround" B and Chad

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  73. 9:06pm, 5:35am, 12:25pm, 12:45pm and 1:03pm (in other words, 6 of the last 8 comments) are all the same person.

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  74. Why does Zimmer Spine get such a bad rap? It seems they have leading edge technology. Also great people running show.

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  75. 10:19PM
    No. You are incorrect. I posted 5:35AM and 12:45PM. The other post are by at least one or more other individuals.
    Frankly, this run of post was actually helpful in learning more about techniques using a new system to perform decompressions. It certainly lacked the typical name calling and throwing sand around as many other post display. If I were a betting man like Romney, I would bet this type of exchange and sharing of ideas is what the Spine Blogger had in mind when he created this site.
    Here's to learning and contributing something positive when you can!
    Cheers!

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  76. 4:42 ARE YOU AN IDIOT? People are sprinting to get awayfrom Zimmer, just look. I'm freinds with several of the reps who work for the guy in the northeast who has half the country.Everyone wants to sprint that situation. I was told he had a christmas party only !0 people showed and he has over 150 who work for him

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  77. 5:02am,

    We aren't stupid. Either all of the posts were you, or you and a fellow Baxano co-worker staged the exchange to spark interest in your product. I have nothing against your product, but I do have something against you for thinking that you could mind f*ck the readers of this blog into thinking that your product is legit just because you say so.

    10:19pm

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  78. 5:50AM
    I don't work for nor do I distribute in any way Baxano products. I merely acknowledged another products capabilities when someone else posted about the iO-Flex. My post had nothing to do with promoting the use of a product, simply to discuss TLIF and PLIF procedures and how spine is continually innovating (some good and not so good).
    To your point about the legitamacy of a product; no statement on this blog is meant to nor should it be construed as providing legitamcy for a product. That is the responsibility of the manufacturers, surgeons and clinical investigators to perform and determine.
    As with most bullies in the sand box, you are love to destroy and attack but add nothing of positive substance.
    Smile, you'll live longer! :)

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  79. i hearde iO-Flex has paralyzed patients from shavings. is Baxano developing anything to keep the shavings from always floating in the body? is there a US IDE to prove the efficacy and safety of this idea?

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  80. 10:19 - I agree.

    Do the facets articulate after they are removed during a TLIF. Hmmmm....I dont know, let's see, they're removed so how in the world can they articulate. Do the tires on my car still rotate after I take them off?!?

    That ridiculous question aside, it looks like a phenomenal product.

    TSB - I would not harp if you sold ad space brother!

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  81. Is Wyss in jail yet?

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  82. Can anyone answer what happens to the debris that is shaved by the Baxano device? By design some of the teeth should carry fragments out of body but certainly some fragments would remain unremoved. What are the risks associated?

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  83. What is the deal with Spineguard is it legit?

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  84. the debris falls into the body. it will never be anything due to many reasons besides the safety issue.

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  85. If the debris is fine periosteal and bone dust, it will be resorbed and gone in a few weeks. Baxano is the only novel concept developed in the last 5 years (and no, I don't work for Baxano, I don't even work in spine anymore...)

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  86. 12:10--well, they're charging $1800 for a pedicle probe and saying it is comparable to neuromodulation, which it isn't.

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  87. 12:46 - for a guy who doesn't work in spine anymore, those are bold words saying Spine Flossing is "the only" novel concept developed in the last five years. Get in or get out.

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  88. 12:10.....you deserve a little better look see. Pediguard is designed to give the surgeon a fail safe (app. 99%+ sensitivity & positive indication BEFORE breaching the pedicle). A bit different than Neuromodulation when this technique tells you that you already committed the problem. Pediguard stops breach of pedicle BEFORE it happens, minimizes fluoro substantially and doesn't change surgeon's technique. Now available in Lenke curved style and slick MIS version. All for $1800 for single order or much reduced for larger hospital stocking. We have just seen the Neuormodulation rep leave the OR recently with tail between legs as it was shown that his equipment had given NO indication of breaches in 6 cases where surgeon confirmed later on xray (rep blamed on nurses placement of leads which he was involved in and surgeon didn't listen). Give them a try....good product!

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  89. 10:33AM
    You made my point.
    If you truly agree with the 10:19AM and 5:02AM post then you must be the same poster for Baxano according to him. Or, as I likely suspect, you posted a comment regarding your opinion about Baxano and are not affilited with the company. Am I right or wrong?

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  90. I thought PEDIGUARD is the service you hire to protect your kid at sport summer camps... I am soooo confused.

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  91. 5:35 - If you want to achieve good decompression of a lateral foremenal stenosis then you must restore the disk height. A TLIF is an inadequate method because in order to insert the TLIF cage you must use a smaller device than is necessary. Undersized cages + Baxano are not the answer man. Stand-Alone ALIF with no posterior instrumentation and muscle disruption is the way to go.

    Large IBD + restoration of normal disk height, and no whack in the back w/ pedicle screws! Yeah baby, that's the way to go!

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  92. Baxano & Pediguard - a solution in search of a problem?

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  93. Love the comments on here, all "know it alls". THIS is exactly what is wrong with this industry, there are a bunch of underqualified morons doing a job they CLEARLY aren't qualified to do. All of you should take the time to understand the products you bash before you comment,, otherwise, which you've proven, you continually reinforce your ignorance to the rest of the posters/ readers of this board. As for the opinions as to what's new/ cutting edge, etc,, simply let market adoption dictate that. If it works, it will be embraced, if it doesn't it won't.

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  94. Thanks 5:17. I guess your just one of those rich little wusses that take their ball home if they can't be QB. Sorry, we must have hit a nerve.

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  95. Nope. I'm the guy who sits right behind the bench and although you think you're a player, heckels you mercilessly because you have no game & you suck.

    Point being, you're probably the 12th man on the NBA roster who simply occupies a seat but yet never even tears off his sweats because you'd be eaten alive if you ever actually made it into the game.

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  96. Zzzzz put me in coach I'm ready to play
    Next topic ?

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  97. Sorry guys pediguard is not cutting edge or new. Nuvasive neurovision has done that for years and less expensive. I would like to how many false positive you get.

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  98. Definitely hit a nerve. Go back to the stands...loser!

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  99. New Topic! Someone please give us some insider info on 2012 acquisitions!

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  100. 7:48- I think someone left bone chips in your head and paralyzed your brain. The same thing happens with the bone shavings as with any other decompression procedure where bone is shaved, irrigation and suction. Baxano is not causing shavings larger than what you would see from a Midas and the shaver is designed to capture and remove the bone and tissue as it cuts.

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  101. We all know Baxano sucks. Let's all stop talking about companies and products that no one cares about. Next topic, please.

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  102. What is the status on the new Medical Device Tax? Will we pay 2.5% tax on gross next year? I heard we will regardless of whether we are profitable or nor. Any perspective on this tax in 2012?

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  103. 1:42 pm, I was in from before you entered high school, and I'm exceedingly happy to get out. There has been absolutely NO real innovation in spine for at least 5 years, if not 10. The last decade has been dominated by a bunch of ethically challenged 'me too' money grabbers at every level. All that's happening to the industry right now is just the harvest of what they sowed. It's over Johnnie! I'm relocating to an area of medicine where patients are being treated because the doctors actually want them to get better.

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  104. The medical device excise tax starts in 2013, it's 2.3% and as of now it is still in place. Though there are some on The Hill who are trying to get it pulled.

    It's a top line tax, so yes it applies whether or not there's a profit. The big boys lobbied hard to make sure it applies to everyone and that there are no exclusions for companies doing less than 100MM, 50MM, etc. That's some good lobbying dollars there folks - it helps to speed up the survival of the fittest model for those with deep pockets.

    My guess, and it is absolutely a guess, is that there will be some threshold established to ensure that small companies don't get trampled. Donkeys and Elephants both supposedly represent the small businesses and they likely will not let them take a beating.

    There will be action, but this congress has shown they are unable, unwilling, or just unconcerned with taking care of things in a timely manner. Next year this will get resolved. Probably a few months before it goes live. People will still get laid off in front of it and companies will be a little leaner going into 2013.

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  105. Thanks 5:57. It great to know that morons aren't the only ones left on this blog. I appreciate your perspective.

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  106. Where do the tiny peek or titanium shavings go when I impact a cage into the disc space? How about the tiny metal dust when I tighten my locking caps? Has to be some dust that's generated by crossing those threads,,

    Regards,

    The Village Idiot

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  107. PediGuard, we looked at it and $1,800 for a non reimbursable disposable of questionable efficacy made us pass. Dealing with their sales manager was also not promising. Good luck to those who attempt this.

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  108. What the heck is going on at Nuvasive? Stock went off a cliff today, at 12.19 the last I checked. 6+ year low. Could it be that MDT's injuction is going to stick? (i.e. XLIF off the market?).

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  109. The Crooks at OFIX will be getting there due's collected now! They have been covering up a bit more then they have revealed, good luck to those SOB's!

    I heard one of there fearless past leaders is at Amedica Blue Tooth Enright, what a joke they hired him to lead the charge, he's anything but a sales leader. He's scared to get in the field and meet with surgeons and work in the field. I feel sorry for there sales team they will be hating him in a few weeks!

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  110. where are the comments on Medtronic settling their whistleblower suit for $23 million? ooops, that was the cardio boyz involved in that one.....would never happen in spine, LMAO!

    http://www.beckersasc.com/stark-act-and-fraud-abuse-issues/medtronic-settles-kickback-allegations-with-235m.html


    seems to me I recall several of the big blue faithful on here claiming "I have never ever paid a surgeon and I don't know any of my sales colleagues that have either!"

    Guess they just hadn't been with the company long enough.

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  111. @1254:
    I heard Alex was changing the company name to
    SuVasive.

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  112. Most companies that rail against PODs pay a pretty heavy dollar in consulting fees. I was curious if that's the case with Biomet. Anybody?

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  113. The surgeons in PODs don't realize what hit them. Between the fees and the majority piece of the ROI, they are hurt as usual. What you don't know won't hurt you!! Ouch, it's the % that hurts! The smart ones beat you to the punch!!

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  114. "@1:03..thanks Tony! now, when are you hiring Roger to ensure that you add more "deformity" to your management team, what with Joe "shortround" B and Chad"

    "Shortround, LMAO, no kidding. Joe is has the business sense of a post and Chad? Lets just say a low life that you want to keep your daughters away from and who barely knows where the spine is located. Why Tony brought these two on as his go-to's is beyond comprehension. Can anyone figure out why?!?

    This definitely hurts Baxano's credibility and its a shame as iO-flex seems to have decent potential. Interesting product.

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  115. Blackstone Medical just recently (Oct 2011) reached settlement of an Arkansas qui tam for $1.8 Million and is now facing the music in a Massachusetts qui tam (Hutcheson v. Blackstone Medical)where the allegations of kickbacks are of national scope. Case set for trial Sept 2012. In the Ark case, allegations were of kickbacks to Dr. Patrick Chan (neurosurgeon, now convicted of kickback violations and expelled from the United States) and Nurse Geff Yielding, sentenced to 78 months in federal prison and fines/restitution of almost $1 Million. Interestingly, the list of Blackstone "consultants" includes not only Chan and Yielding, but also a neurosurgeon in Louisiana (now suspended from practice), ortho surgeon in Nevada (now convicted on guilty plea of aiding a felony, though not related to Blackstone kickbacks), and another former Arkansas surgeon (now barred from practice in that state). Query: Why would a company as well-heeled as Blackstone, with the ability to secure the services of truly distinguished and skilled individuals, select folks like the foregoing to be its, ahem, "consultants"?? 3 guesses, first 2 don't count ...How deep and how far does it go?

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  116. bright delivery of complex ideas! thank you! depuy hip recall lawsuit

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  117. Question from a non neuro nurse...husband just had io flex procedure for L4/L5 nerve root compression. Doc said op went smooth but unable to get to the central foramina due to mild scoliosis. Most of original pain gone but now has an extremely painful top of foot discomfort ie with light touch. Can hardly put sock on but no pain with a full grab of the foot. Walking at times also painful. Thoughts? Did have what we thought was a towel clip puncture below incision requiring compression dressing at home. Hematoma below incision but appeared soft and superficial. So far, doctor says all this should resolve. Now on neurontin and had undergone prednisone taper. New injury? Just finished reading FDA adverse events with Baxano io flex....doesn't seem too bad...yet. thank for info Maybe we should get MRI? out 6 weeks post op now...

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