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

MEQUON, Wis.–(BUSINESS WIRE)–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 15th Annual Meeting of the International Society for the Advancement of Spine Surgery (ISASS), held April 15-17, 2015 in San Diego, Calif.

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="" span="" style="position: relative; top: -0.5em; vertical-align: baseline;">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.The Oral Podium Presentation, “Subsidence Following Dynamic Loading of Intervertebral Devices,” (Abstract #224), was delivered by lead author Dr. Antonio Valdevit on Friday, April 17during the General Session on Biomechanics.

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 this 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.”