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?