As an industry, we have won many battles with the FDA by creatively tailoring language in the submission process on intent and indications of devices. If Dynamic Stabilization can play a role in the treatment of DDD by favorably altering the movement, and load transmission of the spinal motion segment without fusing the segment, is this a new modality of treatment? How is this a supplement or adjunct to fusion? Our readers must answer that question! If instability or abnormal movement is the main cause of back pain, fusion would alway be successful in relieving back pain, yet, this has not been the experience. With the introduction of pedicle screws, inter-body devices and the 360, successful fusion rates have increased, but have failed to improve the overall clinical success rates. TSB understands the argument that "potentially" this product could minimize adjacent disc degeneration by controlling motion, but how much motion? And how much load should be shared by the system to unload the damage disc? Did God create us equally in size, shape and looks?
Based on what one of our readers posted, it seems Zimmer itself is confused. What does "It offers a unique approach to stabilization and immobilization of the spine and pain relief" really mean? And what does " it provides immobilization and stabilization of spine segments" mean? Just attend the Castellvi program in the Keys, and one starts to wonder whether the surgeons themselves understand how to use this device. Do any of these panelist understand the discrepancy in the kinematics between the implant and the motion segment? Or, are they relying on the input of a cadre of academicians and biomechanical experts? Mainly Panjabi, Goel Ferraro, et al????
Put yourself in the position of the FDA. How difficult is it to discern what is clinically relevant and what is clinical marketing? Today, we have surgeons testifying on behalf of the companies and devices that have a vested interest in the products approval and success. Can one potentially lose their objectivity when millions of dollars are at stake? If you and I sat on the panel, what would be the first question we asked? I venture to say that most of you know the answer! Then, we would proceed to evaluate the technology and the data. What makes this such a hot topic is that Spine is always looking for a new product to build momentum, and TDA has lost some of the wind behind its sails. Spine is a burgeoning industry, based on its margins and profitability, that is why it has become the darling of Wall Street. Investors with and without any medical experience have infused a tremendous amount of capital and time into this product segment. Unfortunately, this is a product that needs time and retrospective clinical data to prove its efficacy. At the end of the day, if most of these patients end up with a fusion what have we accomplished? TSB wants to know what our readers believe?