June 13, 2016
MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that it is enhancing its spinal device warranty to provide a free replacement if any of the Company’s Endoskeleton® interbody fusion devices delaminate or generate particulate debris during implantation. The amended warranty is a direct reflection of the Company’s confidence in its proprietary subtractive manufacturing process that was further validated in a recent study published in The Spine Journal demonstrating that the Company’s Endoskeleton® titanium interbody fusion devices generated no particulate debris or delamination during simulated impaction in to the disc space, as opposed to those made with an additive coating.
The company’s initial warranty was first offered in September 2014, and provides a one-time free replacement of any eligible Titan spinal interbody fusion device if revision surgery is required within the five year warranty period, as outlined within the terms of the agreement.
Peter Ullrich, M.D., Chief Executive Officer of Titan Spine, commented, “Since we first announced our warranty in 2014, we have received overwhelming positive feedback from hospitals, surgeons, and patients. We are excited to expand our warranty to now include full coverage of the device if it is ever removed due to delamination or detached titanium particles. Our most-recent study1 has generated spirited debate in our industry whether titanium material stays bound during impaction or not when manufactured using a subtractive versus various additive coating techniques. Our science and our experience in the marketplace that includes over 45,000 implantations has confirmed that the titanium on our devices stays bound during implantation and in-situ, which is critical to ensure patient safety.”
Kevin Gemas, President of Titan Spine, added, “Hospitals and health systems look very favorably on companies who are willing to risk share by standing behind their technologies. We are interested to see which of our fellow interbody device manufacturers are willing to follow our lead and shoulder the liability of backing their devices regardless of patient co-morbidities or the biologic used.”
Titan Spine offers a full line of Endoskeleton® devices that feature Titan Spine’s proprietary implant surface technology, consisting of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN™). 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 The company will soon be launching its next-generation nanoLOCK™ surface technology, which has been shown to create superior osteogenic and angiogenic environments when compared to PEEK and the company’s current surface technology.5 All Endoskeleton® devices, including those that feature nanoLOCK™ surface technology, are covered by the company’s warranty.
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 Kienle, A., Graf, N., Wilke, H.J., Does Impaction of Titanium-Coated Interbody Fusion Cages into the Disc Space Cause Wear Debris and/or Delamination? The Spine Journal. 2016 Feb; 16 (2): 235-42.
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.
5 Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.