[April 20, 2015]

Titan Spine Data Demonstrate Reduced Subsidence of Their Endoskeleton® Titanium Interbody Fusion Implants Compared to PEEK

Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that results of a new study demonstrating a statistically reduced subsidence rate and overall subsidence amount of its Endoskeleton^® TA device compared to a commercially-available PEEK device was presented during an oral podium presentation at the 15^th Annual Meeting of the International Society for the Advancement of Spine Surgery (ISASS), held April 15-17, 2015 in San Diego, Calif.

The Oral Podium Presentation, "Subsidence Following Dynamic Loading of Intervertebral Devices," (Abstract #224), was delivered by lead author Dr. Antonio Valdevit on Friday, April 17 during the General Session on Biomechanics.

The findings, which come from a dynamic mechanical study assessing subsidence rates of spinal implants during continuous cyclic loading, demonstrate that Titan's TA ALIF interbody device provided for a 410% reduction in rate of subsidence and a 40% reduction in overall subsidence amount compared to a commercially-available ALIF PEEK implant of similar footprint (p<0.001).¹ The parameters of the study were designed to reflect the three-month post-operative period in which the incidence of subsidence is most likely to occur in-situ.

Antonio Valdevit, Ph.D., Professor, Department of Chemical Engineering & Materials Sciences at Stevens Institute of Technology, and lead author of the study, said, "Most mechanical subsidence studies for interbody fusion devices are performed statically according to ASTM testing standards. However, from a clinical standpoint, subsidence occurs dynamically under continuous cyclic loading. Our study replicated thi clinical condition and demonstrated that Titan's titanium TA implant resulted in a statistically slower and more gradual settling upon the endplate surface, producing a 'soft landing,' whereas the PEEK implant had a statistically increased settling rate and overall subsidence amount. The PEEK implant's 'hard landing' may be the result of its anti-expulsion teeth that distributed the overall compressive force over a smaller contact area as compared to Titan's roughened macro surface. This study distinctly shows that subsidence is a function of more than the implant's material modulus, but also importantly involves device design, which may have meaningful clinical implications."

Andrew Shepherd, Vice President of Marketing of Titan Spine, commented, "The importance of this study cannot be overstated. The spinal community has long been led to believe that subsidence is purely a function of an interbody device's material modulus and that PEEK implants will subside less than titanium devices since PEEK's modulus is closer to that of the vertebral body. Dr. Valdevit's study directly refutes this myth and confirms what the biomechanical community has always known. Implant design plays a much larger role in subsidence than the implant's modulus of elasticity. Titan will continue to design its implants based on scientific principles rather than marketing misconceptions to drive sales."

The full line of Endoskeleton^® devices features Titan Spine's proprietary implant surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and cellular levels. This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.^2,3,4

About Titan Spine

Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton^® interbody devices featuring its proprietary textured surface in the U.S. and portions of Europe through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

¹ Valdevit, A., Ullrich, P., Gallagher, M.B., Schneider, J.M. Subsidence Following Dynamic Loading of Intervertebral Devices. Abstract #224, Oral Podium Presentation; ISASS 2015.

² Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399-404.

³ Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.

⁴ Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate osteoblast production of angiogenic factors. The Spine Journal, 13, 1563-1570.

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