MEQUON, Wis.–(BUSINESS WIRE)–Apr 15, 2013–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, announced today that clinical data support the use of its Endoskeleton titanium interbody cage for achieving rapid lumbar fusion and improved patient outcomes. The prospective study was presented at the 13 th Annual Meeting of the International Society for the Advancement of Spine Surgery (ISASS), held in Vancouver, British Columbia, April 3-6.
Andrew Shepherd, Vice President of Marketing for Titan Spine, said, “Titan Spine is focused on optimizing the surface of interbody implants so that they can play an active role in facilitating bone integration and promoting fusion. This prospective study, which echoes similar clinical experiences from other surgeons in the U.S. and abroad, included patients of varying ages and degenerative conditions who all successfully fused and experienced excellent clinical improvement with our device. We look forward to continued research into the application of our proprietary technology and its impact on fusion outcomes.” The study looked at 77 patients with a mean age of 46 years who underwent an ALIF procedure using the Endoskeleton ® interbody device. A total of 138 spinal segment levels were treated, and radiographic analysis by two independent radiologists revealed a 100% fusion rate between 6 and 12 months, with no appreciable subsidence and an interobserver reliability rate of 95%. Researchers also noted that clinical outcomes as determined by ODI and VNS scores improved significantly by six months (ODI≥15 and VNS≥3), with the improvement sustained at 12 and 24 months follow-up. They concluded this was likely due to early bone incorporation at the implant surface and lack of subsidence.
Titan Spine’s Endoskeleton ® implants feature a proprietary acid-etched surface that is textured at the macro, micro and cellular levels to support bone purchase and new bone growth. Cellular research has demonstrated the surface promotes a superior bone-forming response as compared to smooth titanium and PEEK implants.
Lead author Paul Slosar, MD, of SpineCare Medical Group and the San Francisco Spine Institute in San Francisco, CA, said, “This study supports the use of the Endoskeleton device for safe, effective and rapid spinal fusion. It is also important to note that fusion status was able to be determined in all patients due to the design of the implant, which is in contrast to the difficulty in assessing fusion in historical titanium threaded devices. The Endoskeleton’s unique surface has been shown in published cellular research to stimulate improved osteoblast differentiation to support fusion. Our clinical data further substantiates those findings, and demonstrates the notable positive impact on patient outcomes.” The Oral Presentation, “A Prospective Study of a Unique Titanium Interbody Fusion Implant: Clinical and Radiographic Outcomes at 1 and 2 Year Follow-up,” was delivered on Friday, April 5 as part of the Cutting Edge Technology session.
Titan Spine markets a full line of interbody devices for use in the lumbar and cervical spine. For more information about Titan Spine and its unique surface technology, visit www.TitanSpine.com.
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, headquartered in Mequon, Wisconsin, markets a full line of Endoskeleton ® interbody devices featuring its proprietary textured surface. To learn more, visit www.titanspine.com.
