Thursday, November 12, 2009

Lumbar Care: Is This Innovation?

TSB has had a hectic week! In the spirit of competition, we wanted to review some of the products that were "in the running" at the Spine Technology Awards Banquet by category.

Since Lumbar Spine is the largest segment in our industry, we would like to provide our readers with a snap-shot of the entrants for this segment;

Alpha-Tec: Osseo Expandable Pedicle Screw
Biomet Spine: Polaris Deformity System and Trivium Derotation System
Custom Spine: AVID (Articulating Vertebral Interbody Device)
Disc Motion: InLign Multi-Axial Screw
Integra Spine: VuaPod
LDR Spine:ROI-A Cage with VerteBridge Plating System
Ouroboros: OSS Spinal System
Paradigm Spine: DSS Spinal Stabilization System
Pioneer Surgical: BacJac Interspinous Decompression System
Pioneer Surgical: NuBac Nucleus Replacement
Spinal Elements: Lucent Controlled Delivery Gun
Spine 21: Bionic Spacer
Spinous LLC: ANDRE (Aspirating Neurological Dissector & Retractor for controlled Exposure)
VTI: InterFuse Interbody Fusion Device
Woodweilding SA: Lumbar Minimally Invasive Care Biomaterial

If our readers look at the products, they ranged from Pedicle Screws, to Dynamic Stabilization Systems, Intervertebral Spacers, Instruments and Bio-materials. This was a wide range of products to choose from. Some old, some new, some borrowed, and some blue. As with many of these technologies, the reader must ask themselves; "Is This New? Is This True? and Will The Device Make a Difference?"

Does an expandable screw make a difference? There is no doubt that a screw of this design improves axial pullout load, but have we had a problem with pedicle screws pulling out? Isn't marketing a company's portfolio to the "aging population" an attempt to exploit senior citizens? It's almost as fickle as gender based knees. I guess its difficult to argue with a company that is on target to hit $100 million in revenue this year. Yet how much revenue will this product truly generate? And the question must be asked; how much of your business will you cannibalize?

How about an articulating TLIF device? To claim that current technologies have a smaller footprint, and require manual manipulation to insert a spacer in the optimal location is a fallacy. Approach and technique solves many challenges when inserting IBD's. Just look at the XLIF, or for that matter the new GLIF! This AVID also needs manual manipulation, by a very primitive looking instrument. There are many companies in the market that have spacers this size after this device is activated. Besides, when you have investor surgeons willing to present at NASS on behalf of the product, red-flags must be raised as to the claims regarding potential efficacy.

If there was any product that was interesting it had to be the Vertebridge Plating Technology and the InterFuse Device. TSB does not have any commercial interest in either of these products, nor affiliation with the management in these organizations. Yet, our readers must admit that there has been many questions raised about instrumentation when it comes to Zero-Profile instrumentation, and LDR seems to have found an easy 2-Step, 2-Instrument Implantation System. In addition, the InterFuse does have some cool features.

As usual, Hansen Yuan's name was attached to a multitude of products. What hasn't he attached his name to over the last few years? For all of Hansen's tremendous contributions in the field of spine and neurosurgery, he has taken the commercialization of medicine to a new level.

At the end of the night the audience had to ask itself; were some of these products creative and innovative? What is the long-term significance of some of these technologies and do they have the staying power? Does this solve a clinical problem? Can this improve the standard of care? Will this technology be cost effective, not only clinically but also sociologically. Would you want that device implanted in your back?

In closing, many of the legacy companies, the real players in the industry in terms of market share, did not submit entries. These companies do not need to affiliate themselves with Robin Young to attain critical mass, or market presence. Many "mid-cap" companies were in attendance for the obvious reasons. Yet, it always comes down to publicity! Once again, this venue exhibited the incestuous pathology that exists in our industry. Until we find another platform, we have chosen our master! In closing TSB wants to know what our readers believe?


  1. As a Biomet rep and therefore having an obvious bias, I still beleive that the Trivium derotation system provides scoliosis docs with a powerful tool in correcting the axial component of their complex curves. That being said, docs are seeing better corrections, made easier, than were possible in the past.

  2. "Does an expandable screw make a difference? There is no doubt that a screw of this design improves axial pullout load, but have we had a problem with pedicle screws pulling out?"

    How about problems screwing it in? From the looks of it, it may have weak spots along its length. Who wants a broken screw stuck inside his/her spine? How in the world will you ever take it out? I am sure AlphaTec will report such failures, if any, to us. Won't they? :)