Titan Spine is to provide a free replacement if any of the company’s Endoskeleton interbody fusion devices delaminate or generate particulate debris during implantation, updating the product warranty.
According to a company release, the amended warranty reflects Titan Spine’s confidence in its proprietary subtractive manufacturing process. A study recently published in The Spine Journal has demonstrated that the Endoskeleton titanium interbody fusion devices generated no particulate debris or delamination during simulated impaction in to the disc space, in contrast 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, chief executive officer of Titan Spine, comments, “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 study has generated spirited debate in our industry as to 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 have confirmed that the titanium on our devices stays bound during implantation and in-situ.”
Titan Spine’s implant surface technology, consists of a unique combination of roughened topographies at the macro, micro, and nano levels. This 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, downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.
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. All Endoskeleton devices, including those that feature nanoLOCK surface technology, are covered by the company’s warranty.