Wednesday, November 4, 2009

Zero-P, No it's Not L'il Wayne's Side Kick!

Zero-P, it sounds like a Hip-Hop or Rap artist! It's the latest craze spreading through the spine industry. Using Cervical Plates with Cervical PEEK has become out of vogue. Spinal Elements can take credit for being the first legitimate commercial product to create a shift in treating cervical related disease. Yet, when SurgiCraft, a British based medical device company launched the STALIF TT PEEK, a stand alone ALIF device with screws, it set off a frenzy of spinal implants that would be built off these platforms. Since that time, it has become apparent that companies in our industry have been off to the races, attempting to beat one another to the market with a sleeker and more user friendly design. This product not only had ALIF applications, the design opened an entire new modality of treatment for the cervical market place. With the commoditization of cervical plates, resulting in hospitals paying on average of $1,000 - $1,500 per procedure (someone selling in NY told us that some hospitals have capped plates at $865 for one and two levels) these products have allowed spine companies to once again maximize their profits. Yet, one of the major concerns seems to be the simplicity and efficacy of the instruments. As with most implants, instrumentation is the key to an immediate revenue explosion. Realistically, how different are many of the implants that we sell? TSB argues that it always comes down to the instruments.

In retrospect there were some companies that attempted to get into this market segment. The companies that failed were Scient'x and Interpore Cross. If my memory serves me, Interpore's product was called the Vanguard. Today we have multiple companies that offer so-called zero profile cervical products. These include; Mosaic by Spinal Elements, which set the precedent for cervical devices and is still considered to be a good product. Bricon, a German company has a product called Cervical-C or Shark Cage, LDR has a product called ROI-C with its VerteBRIDGE plating technology. TSB must ask is there any biomechanical data on the efficacy of those blades that are used to stabilize this device? Centinel has the STALIF-C which has been struggling because of the V Brothers inability to transition anything smoothly. Synthes has the Zero-P, and Globus has a product of their own. In addition, to these devices there are a few smaller ventures that are playing in this space.

The most common complications associated with the anterior approach to the c-spine are sore throat and dysphagia. Yet, chronic dysphagia or hoarseness is an uncommon complication associated with injury to one of the recurrent laryngeal nerves. This type of injury may cause problems with swallowing and potential aspiration. But the question must be asked, have these post-op complications been a by product of surgical approach and soft-tissue management, or has the implant really been the culprit? TSB wants to know what our readers think?


  1. These Zero-P implants have more differences than just their instruments. Take for example Synthes Zero-P vs Globus' version. 4 locking screws vs 2 variable angle screws that are blocked/toggling. Zero-P has stability comparable to a plate and 4 screws as shown in a published Spine article. Where's the data on the Globus device? or RSB? or MSD's device? There not showing it if there is and there's probably good reason.

  2. LDR is having huge success with thier VerteBRIDGE plating system. They have teamed up with some very big players that do not have this technology in their product portfolio around the country(ie Depuy, Styrker etc). I currently work as a rep for Depuy and this technology has opened so many doors and got praise from nearly all my surgeons using both the alif and cervical version. It requires only two setps and two instruments to implant the device and it truly is less invasive than the competition (no difficult screw angles,bulky instrumentation, jointed screwdrivers etc). Recently they just published new biomechsanical data comparing it to other stand-alone products and conventional plating systems. The results looked great and surpesingly was stronger/non-inferior in flexion, extension, lateral bending, expulsion and axial rotation. Bottom line is that these products have been taking business from the first generation zero-profile systems, keeping competitors away from my surgeons, decreasing or time and making my surgeons life alot easier. This has been the most innovative product we have been able to sell at my Depuy distributorship in some time. I am just hoping this company doesnt get sold anytime soon, especially since they have a cervical disc with a 2 level indication coming out in 2011.

  3. Mr. DePuy rep, if you want to see why locking screws are better then a tab, I can send you an xray of patient that had a L3-L5 posterior fusion and when 5/1 degeneraterd they had an ALIF with LDR. Patient developed a grade 2 Spondy and the superior tab cut through the body of 5 and pulled out half way. Patient has now had another procedure to revise to the ilium. Great device, not. Will not be using this device anymore, going back to locking screws.

  4. What will be the impact of the 22845 code disappearing on zero-profile devices? NASS states that surgeons should not bill 22845 and 22851 for zero-profile IBFs. In order for 845 to be included Nass states "it must be a seperate construct than the IBF."

    This has been one of the fastest growing segments but...