STS and SAS: Innovation, Consternation, and Dedication

The 2007 Spine Technology Summit (STS) and the seventh annual meeting of the Spine Arthroplasty Society (SAS7), both held this past week in Berlin, featured big companies, micro companies, and surgeons from every corner of the world and every philosophy of medicine. Topic A? Products that promise in some way to do a better job for patients and surgeons than the bread and butter of today's $6 billion spinal implant industry'spinal fusion.

Not to say spinal fusion is dead-far from it. In fact, the most interesting side story remains new instruments, approaches, and techniques that are delivering improving fusion outcomes.

But with a potential 19-billion-dollar market value in the coming decade, preserving and managing motion in the back was the point of the meeting.

At the Spine Technology Summit, which has become the premier event for new technology and companies in the industry, about 40 speakers reviewed 75 spine care technologies. Moving from technology and commercial presentations to scientific presentations meant transitioning in the final days of the week to SAS7's location and meetings. Here, approximately a mile from the Spine Technology meetings, SAS's surgeons and scientists presented their posters and papers to filled rooms. Among the elements that elevates SAS's meetings is the global nature of the presentations and audience.

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Innovation

All of us who've devoted our careers to orthopedics and technology know that the explosion of innovation currently occurring in the spinal implant industry is unprecedented. At the end of the Spine Tech Summit's first day, it truly felt like that hoary old saw, 'drinking from the firehose.' Where did all of these ideas come from? And perhaps more importantly, who's funding it all? Here are our notes.

Most innovative
Spinal Kinetic's 'natural' artificial disc. These are obviously some innovative guys. Think two plates, a gel-filled middle, cross hatching cords connecting the top and bottom plates and a polymer jacket surrounding the whole assembly. This design caught everyone's attention and it did mimic the natural vertebral anatomy kind of, sort of, maybe'but more directly than other designs we've seen.

Axial Biotech's DNA-based predictor for scoliosis was one of the strongest presentations. Recently, DePuy Spine announced that they had made a strategic investment in Axial Biotech.

  1. Most Innovative
    1. Spinal Kinetic's 'natural' artificial disc.
      These are obviously some innovative guys. Think two plates, a gel-filled middle, cross hatching cords connecting the top and bottom plates and a polymer jacket surrounding the whole assembly. This design caught everyone's attention and it did mimic the natural vertebral anatomy kind of, sort of, maybe'but more directly than other designs we've seen.
    2. Axial Biotech's DNA-based predictor for scoliosis was one of the strongest presentations. Recently, DePuy Spine announced that they had made a strategic investment in Axial Biotech.
  2. Innovation Plus Speed to Market
    1. NuVasive's NeoDisc.
      No other product looks like NeoDisc, with its woven structure. Now in human trials, this simple design will, we think, rapidly attract plenty of surgeon support and interest.
    2. Nubac.
      Clever, simple design. Under Matt Songer's leadership at Pioneer Surgical, Nubac is setting speed records going through its approval and testing process. Think Fernstrom Ball on a skateboard.
  3. Surprise!
    1. Globus Medical's FOUR motion preserving designs. Not only posterior total disc replacement (TDR), but also transforaminal TDR, anterior cervical TDR, and an interspinous device (Flexus). Globus and Medtronic Sofamor Danek have the most motion-preserving devices in advanced stages of development and clinical testing.
    2. Disc Motion's TrueDisc technology combined a posterior approach with dynamic stabilization system AND disc replacement in one package. That was news for many of the attendees.
  4. Yawns and Groans
    1. Scient'x Isobar. Sorry to pick on our friends from Scient'x and the well studied Isobar, but, four-year-old data? Isobar was the first dynamic rod approved by the FDA (as an adjunct to fusion). After a decade of clinical use in the United States, we're pretty sure more current and complete data is available. A lesson for all managers of innovation: in the world of medical technology, the need for constant data collection and evaluation never ends.
  5. Tried and True, and a Little Underappreciated
    1. Charit'. The original clinical data was good. Five-year follow-up data are on the way and are expected to show much lower revision rates and continued high patient-satisfaction rates. PLUS ... the Center for Medicare and Medicaid Services' (CMS's) own data shows that Charit' is no more expensive than fusion and likely even less expensive.
    2. Hydrocision's family of fluid jet systems are ideal for the coming new generation of spine technologies. Every single nucleus replacement company stated that proper excision of disc material was key to successful implantation. That's Hydrocision.

Very notable mentions include Replication Medical's NeuDisc, Annulex's annular repair system, IST's Paramount, Paradigm Spine's CoFlex (with a huge amount of data) and TranS1's PNR' percutaneous nucleus replacement system.

Consternation

Behind every silver lining there is a cloud. For the spinal implant industry, two clouds in particular loomed on the horizon at SAS7. They are reimbursement and diagnostic tools. CMS, through its public pronouncements, its special committee meetings (like MCAC), and its annual inpatient payment proposal, has been setting the agenda.

for both public and private reimbursement policy for quite a while. These past couple of years, CMS has refused to reimburse hospitals for the cost of lumbar disc arthroplasty (i.e., DePuy's Charit' disc) and then proceeded to attack spinal fusions. CMS's public statements regarding fusion have been as follows:

  • 'We have fundamental concerns about the adequacy of the evidence for fusion surgery in general.'
  • 'Spine fusion for the indication of discogenic pain is controversial with conflicting results from clinical trials.'
  • ' Fundamental problems plague the study of spinal fusion, including the lack of definitive methods to confirm a solid fusion, a weak association between solid fusion and pain relief, and the placebo effect of surgery for pain relief.'
  • 'The use of fusion is variable, with unclear indications.'

"What are we going to do about reimbursement?' was the universal comment from the podium and on the floor, for sure. But we also heard about multiple efforts being organized (principally through SAS but also at Medtronic and DePuy) and new patient data sources being tapped (principally PearlDiver) to tackle reimbursement for new technology.

Specifically, SAS, which is a true advocating society for spine surgeons, and its new president, Hansen Yuan, M.D., are marshalling data and people resources to give CMS and private insurers the case for funding surgeons and hospitals who want to use new technology to advance spine care. Dr. Yuan's focus is on establishing the metrics for measuring spine fusion performance and in that activity to set up the process for justifying adequate surgeon, hospital, and implant reimbursement for new technologies.

Diagnostic tools, unfortunately, are emerging as spine technology's speed bump. This $6 billion industry, which treats over 1 million patients annually and is expected to treat more than 2 million patients in just another six or seven years, is based on three basic procedures: fusion, vertebroplasty/kyphoplasty, and disc excision. If EVERY new product we saw this past week came to market, the range of treatments for back pain would explode.

This rosy picture hits a five-foot-tall speed bump at the level of the physician / patient interaction when the surgeon has to decide which new treatment will address the pain his particular patient is feeling.

Asking a panel of spine surgeons, some of whom are inventors of new technology, how would they select a patient for nucleus replacement versus, say, dynamic stabilization produced a series of inexact answers. And these are very smart guys and gals. Today's diagnostic tools are not adequate for the current technology (we still can't reliably identify the specific pain generators for every back pain patient). How will they meet the demand of all of these treatment choices?

Dedication

The Spine Technology Summit and SAS7 were both held in Germany, specifically Berlin. That country, as we chronicle in a companion piece, holds a very special place in the history and future of spine care. Karin B'ttner-Janz, co-developer of the Charit' disc and professor at the Charit' Universit'tsmedizin Berlin, opened both meetings. The influence of Rudi Bertagnoli, chief of spine service, Klinikum, St. Elizabeth, and codeveloper of the ProDisc, was everywhere, and his ProDisc work will likely kick-start lumbar arthroplasty throughout the world. Dr. Hans Jorg Meisel, chair department of neurosurgery BG-Clinic Bergmannstrost, and whose work in spine biologics will contribute significantly to the next chapter of the history of spine care innovation, was there all week.

Dedication to spine surgeons and better spine care was by far the most powerful and universal message of the two meetings. Incoming SAS president and former North American Spine Society president Dr. Hansen Yuan has dedicated a huge swath of his professional life to this GLOBAL society of spine surgeons. Last year he devoted about a couple thousand hours of his time to establishing the SAS Journal. This year he is leading efforts around the globe to improve education and reimbursement for surgeons and hospitals as SAS's new president (will someone please just give him a private plane'if only for the next 12 months?).

Dr. Yuan is not alone. He gets picked on in these pages because he is the most visible this year, but we talked to more than a dozen other senior surgeons and scientists who have committed themselves to working with other surgeons, reimbursers, and the societies to elevate the practice of treating back pain patients.

One of the many highlights of the meeting worth mentioning was our chance last week to spend time with Dr. Charles Ray, founder of the RayCage and Raymedica's PDN. He's a little older now but his opinions and observations remain insightful and outstanding. His company is now under the tutelage of John Viscogliosi and doing well. Speaking of the V. Brothers: they were the catalysts behind the original SAS and, indeed, the entire arthroplasty movement. Under the heading 'dedication' they get the final word and hopefully, as they looked over how large and important these two meetings have become, Tony, Marc, and John take great pride in their role as founders, promoters, and visionaries.

Written by Robin Young, CFA