Titan Spine is expanding 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 decision to amended the warranty followed a recent study published in The Spine Journal demonstrating that the Endoskeleton titanium interbody fusion devices, produced using a proprietary subtractive manufacturing process, generated no particulate debris or delamination during simulated impaction into the disc space, as opposed to those made with an additive coating, according to the company.
The initial warranty in 2014 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.
“Since we first announced our warranty in 2014, we have received overwhelming positive feedback from hospitals, surgeons, and patients,” Peter Ullrich, MD, CEO of Titan Spine, said in a statement announcing the warranty adjustment. “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.”
He added that the recent study “generated spirited debate” over whether titanium material stays bound during impaction when manufactured using a subtractive versus various additive coating techniques, but that more than 45,000 implantations confirmed that the titanium on the devices stays bound during implantation and in-situ.
According to the company, its Endoskeleton implant surface technology consists of a combination of roughened topographies at the macro, micro, and nano levels. The combination is designed to create a 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 fusion.
Titan Spine, located in Mequon, WI and Laichingen, Germany, markets the devices in the U.S. and portions of Europe.