Bloggers of the spine world, during the late 70's and early 80's there was a British tele drama called the Sandbaggers. The Sandbaggers were a highly trained group of MI6 officers trained in espionage and deception. Well never fear, a real life sandbagging may be in the works emanating from the Garden State . It seems that on May 12, 2010 there was a contract law suit filed on behalf of Tom Errico, M.D., against the Almighty Stryker Corporation (always say that with reverence), in the Southern District Court of NY.
The impetus for the suit lies in the minutiae of Stryker's acquisition of the Flexi/CerviCore TDR from Dr. Errico. Like in any acquisition of this magnitude, there are always provisions and milestone's attached to remuneration paid in multiple tranches. Word on the Street is that Stryker seems to be dragging its feet, or sandbagging with the PMA submission. Could this be a deliberate act of deception on their part? Could this be attributed to the disc being an albatross around Stryker's neck? Where's Dennis Stripe and Mike (da Bulldawg) Manelli when you need them? Haven't these parties traveled down this road before? If I'm Errico, I need to cash out, stop dreaming up of more innovations, get on my yacht "the Stugotz" and go fishing. Sometimes a man's got to know his limitations. Looks like someone may be in for a haircut at Stryker. You know what they say, "a deal is a deal, regardless."
It seems with the holiday season upon us, the gift of giving is being exacerbated by one law suit after another in our industry. I guess at least the lawyers are making money. TSB wants to know what you've heard on the Street, and what you've heard in the court of public opinion.
Mainelli was not part of that acquisition...this was Scannell's deal with MacMillian
ReplyDeleteWe know. We liked the dynamic duo when they were at Stryker.
ReplyDeleteDuring the disc acquisition rage Stryker was the ugly kid at the dance and had to settle for what was left. TDR is in a coma until insurance jumps on board, even then it will never be a dominant product after the taste it left with docs.
ReplyDeletePay up Stryker, don't worry you still have Mantis to fall back on...nevermind.
What about Stryker's (SpineCore's) cervical disc, CerviCore? Also, will cervical discs fair better than lumbar discs?
ReplyDeleteWhy are the Big 5 or the Big 10 companies getting hung up on cervical arthoplasty?
ReplyDeleteMy homerun pt (and any surgeon) is a one level acdf. Fusion rates are above 97% Any plate bone/synthetic cage combo...
why screw this up?
Revision cervical disc pt = corpectomy
arthoplasty lumbar/cervical is a marketing tool to get pt's in my clinic
Why is this a must need for the Big Companies?
because clinical outcomes for cervical discs are pretty good. i don't know about you but i like being able to move my neck. doesn't work for lumbar because the technology hasn't caught up with the necessary load bearing characteristics. americans are fat and it's tough for a fragile little spring mechanism placed in your lower back to carry all of it around
ReplyDeleteAgree w/ 1:11,, Patients don't want multi level cervical fusions as they lose they're range of motion. While ACDFs work very well,, patient are smarter now and educating themselves and understand & are aware that there are options to being fused and many want to preserve their motion & flexibility in their neck. As for lumbar discs, once the ALL is sacrificed, there's no containment for the implant,, and w/ so many patients overweight & out of shape, it simply creates a recipe for disaster.
ReplyDeleteThis Cervicore disc destroyed my life !!!!!!!!!!
ReplyDeleteWhy did it destroy your life? Elaborate!!!!!
ReplyDelete1:37 I disagree... Cervicore Rocks!!!
ReplyDeleteMain distinction between Cervical TDR and Lumbar TDR is indications. Cervical discectomy and reconstruction for radiculopathy is a home run. Lumbar discectomy and reconstruction for low back pain is successful in only 60-70% of patients.
ReplyDelete@12:55 For the same reason the ACDF is such a great operation for you, the cervical TDR will be as well. Most of the newer TDR designs don't require corpectomy for revision, and who knows, fewer patients might end up with adjacent segment degeneration in the long run as a result. Certainly if multiple levels are involved, they'll have more mobility or reduced adjacent level stresses in the meantime with a TDR or hybrid TDR / Fusion.
But if you want to play it safe and wait for the longer term results, never any fault in that. As you say, don't mess with what works is always a good strategy.
And for 1:37, any patient that thinks they know better than their doctor what's right for them is a fool... and not seeing the right doctor. I don't board a plane and tell the pilot at which altitude to fly, and patients shouldn't tell their docs which procedure to do either. Nobody knows whether TDR will measure up to ACDF in the long run. For risk averse docs, and risk averse patients, ACDF is clearly still the better choice. Those who are willing to take a little more risk to be sure to have / provide the "latest and greatest" will also probably be happy they did.
Cervical TDR and Stand Alones are coming to the forefront because of coding. Starting in 2011-2012, ACDFs will be billed as 1 code, meaning surgeons will make even less money. TDR and especially stand-alone have numerous codes..perfect for hybrid constructs.
ReplyDeletePlease explain how a stand-alone will be coded differently than an ACDF? It's the exact same procedure - decompression, interbody, plate and four screws ... so why would the implant change the code?
ReplyDeleteSounds like Orthofix advice to me.
5:17 would you care to divulge where you heard that info? I heard it too and I believe we both got it from the same source.
ReplyDelete5:17
ReplyDeleteI agree with 7:30. How are the all in ones any different than a plate and spacer/bone? If anything, since they are not technically plates, I don't see how they would get more codes.
ACDF's and Cervical arthroplasty will be within $100 of each other this year, as far as reimbursement goes. With the financial incintive equalized, watch how many surgeons stop dragging their feet and start using the new technology.
ReplyDeleteThe new bundling code is 22551 for Cervical Arthrodesis plus Discectomy. This will replace 22554 (arthrodesis) and 63075 (discectomy) starting January 1, 2011. See the "Federal Register" for the new RVU's under the interim RVU's section. Cervical arthroplasty cpt code is the same code of course 22856. The two procedures, ACDF and C-TDR, won't be $100 from each other but they will come closer than they are now. NASS apparently will publish the new recommended coding guidelines right after the New Year.-CG
ReplyDeleteThanks Charlie
ReplyDelete11:38
ReplyDeleteYou hit the nail on the head. Arthroplasty hasn't been slow to achieve acceptance ONLY because of the insurance companies. It has been better coding for reimbursement to the surgeons and they don't want to sign on to new technology that hurts their bottom line. Give me a mobile disc segment which preserves lordosis over a flat ACDF any day of the week.
I like acdf.
ReplyDeleteYou didn't hear this from Anon-21,OK, but word on the street is that the original Errico CerviCore Disc had been trashed, the study closed by FDA and relegated to the dustbin for "Trials of Devices not approved or cleared by USFDA" http://clinicaltrials.gov/show/NCT00588601
ReplyDeleteCheck out the archives - the match to this is the CT - 002-04 number for NCT00588601 that is one the original consent form for Errico's disc.
It is now suspected that an inside Orthopaedic Stryker Surgeon has modified the design and added osteoprotein to the coating to enhance osseous fusion pursuant to a patent held by Stryker since 1994.
"United States Patent 5,344,654
Rueger , et al. September 6, 1994
Prosthetic devices having enhanced osteogenic properties
Abstract
A prosthetic device comprising a prosthesis coated with substantially pure osteogenic protein is disclosed. A method for biologically fixing prosthetic devices in vivo is also disclosed. In this method, a prosthesis is implanted in an individual in contact with a substantially pure osteogenic protein, enhancing the strength of the bond between the prosthesis and the existing bone at the joining site.
Inventors: Rueger; David C. (Hopkinton, MA), Kuberasampath; Thangavel (Medway, MA), Oppermann; Hermann (Medway, MA), Ozkaynak; Engin (Milford, MA)
Assignee:Stryker Corporation (Kalamazoo, MI)
Appl. No.: 07/901,703
Filed: June 16, 1992"
The mysterious disappearance of Old Cervicore and Older FlexiCore mystery continues.........
ReplyDeleteThere are whispers that this insider Stryker CT OrthoSurgeon is one of MacMillan's long time OP-1 researchers. He covertly modified the Errico design so that he could time the Neo- Cervicore disc to start implantation during the 2008 PMA phase -- and that he planned to initiate his very own covert study in early 2008 using the original IDE application for the 2005 CerviCore study as deep cover. Pretty sneaky aye?
As it turned out, the sneaky insider research surgeon did not get the memo from Stryker Spine regarding the FDA closing recruitment for Errico's CerviCore disc back in 2007 - ostensibly based on the FDA finding rat holes instead of manufacturing plants during the surprise inspections of the Ireland and New Jersey plants. It seems this insider research surgeon was travelling all over the globe lining up new orthosurgeo-buddies outside earshot of the FDA to test market his revised op coated enhanced Neo-Cervicore disc, He was clever to use his own covertly selected candidates who fell into the clinical trial category of "dumb, dumber & dumbest" a/k/a indigent, uninsured and in severe pain.
These powerless subjects had no idea what was going on and thought that they were volunteering for the once legitimate CerviCore study - as was advertized all over the internet and via every spine board. No one knew "what the stryker" was going on until they went to clinicaltrials.gov.
Once at the newly mandated (by US Public Law, September 27, 2007) FDA clinical trial database -- absolutely nothing could be found on the FDA website (newly designed for transparancy to the public)for the New Adventures of the Old Cervicore study.
Every year the same old Stryker 10K report would push the PMA application date for CerviCore and Flexicore another year forward: from 2008 to 2010 -- and now 2011 is here and no one has a clue about where these two highly anticipated studies were hiding out over at the FDA.gov projects or when they would yeild the stockholders the promising profit sharing harvest that Stryker had been teasing the public with since 2004 and a half billion dollars later.
If anyone can find the CerviCore or Flexicore studies legitimized with a bonafide FDA link at clinicaltrials.gov I will rip my 2008 Neo-CerviCore disc right out of my C5 C6 singlehandedly on Reality TV.
Happy hunting CerviCore afecionados....and Good Luck Errico with your law suit. If this Post a Comment helps in any way of your finding your Old Cervicore and Older FlexiCore IDE & PMA applications at that Stryker Spine facility (always a mess when I visit, too) -- let me know. As for now - Anon-21 out.
I'm having my 5 year post surgery exit visit today. I had my cervicore implanted in St Louis, MO @ Barnes Jewish by Dr Neil Wright in March 2006. Still having pain, numbness, lose of strenght, and dropping things out of my hands.
ReplyDeleteWhat Now?
To: Anonymous March 2, 2011 - This is Anon21. I would like to hear from you in private. I can give you an update on my issues and complaint filed w/ FDA. email philomena.55 at gmail dot com. Put CerviCore in subject line - I'll get back to you immediately. I'm in touch with several CerviCore veterans - all are in terrible shape. PIs ignored adverse event complaints - trial was kicked to "trials not approved or cleared by US FDA" dustbin - NCT 00588601 - sponsor study id CT - 002-04. We are talking about combining forces and taking legal action. Did your PI do a metal allergy test prior to implant of cobalt chronium nickle molybdemum titaium sprayed coating? There is something very aberrant about this trial - FDA is investigating complaints - but hard to get anything out of them until their investigation is cliosed.
ReplyDeleteIn 2004 the Company acquired all of the outstanding stock of SpineCore, Inc. (SpineCore), a developer of artificial lumbar and cervical discs for an upfront payment of $120.0 million in cash plus certain transaction costs. Terms of the transaction also include potential milestone payments of $95 million upon commercialization of the FlexiCore lumbar artificial disc in the United States and $120 million upon commercialization of the CerviCore cervical artificial disc in the United States as well as royalty payments of up to an additional $25 million depending on the level of actual commercial sales of these devices, if any. The potential milestone payments are expected to be capitalized at their fair values as intangible assets at the time of payment, if they become due.
ReplyDeleteIn October 2010 the Company made the decision to withdraw its application with the U.S. Food and Drug Administration (FDA) for the approval of the FlexiCore device. The CerviCore cervical artificial disc remains under development at this time; however, the Company continues to monitor the market, costs and approval process associated with the CerviCore device to determine whether the device will be made commercially available and result in the introduction of new products and additional future sales. In addition, unanticipated issues may arise that could further delay or terminate the development of the CerviCore device prior to regulatory approval or commercialization, which could have an unfavorable impact on the Company’s operating results.
http://yahoo.brand.edgar-online.com/displayfilinginfo.aspx?FilingID=7738829-791-374038&type=sect&dcn=0001193125-11-039845