Paul Slosar, M.D., says it’s the first time in his experience that a device company in the spine market has offered a warranty for its devices.
Titan Spine Claims First Warranty Offer of Devices
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One-Time Free Replacement
On September 8, 2014, Mequon, Wisconsin-based Titan Spine, LLC announced it is offering a warranty for its Endoskeleton line of spinal interbody fusion devices. Through the warranty, Titan Spine 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.
Slosar, who is the company’s chief medical officer, added that Titan’s line of interbody devices has a “unique advantage with its ability to promote specific cellular behavior that supports an advanced environment for bone growth and fusion. This warranty highlights the recognition that our engineered spine implants continue to lead the surface technology space.”
Proprietary Surface Technology
Titan’s proprietary implant surface technology consists of a unique combination of roughened topographies at the macro, micro, and cellular levels. “This combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting new bone growth, encouraging natural production of bone morphogenetic proteins (BMP’s) and creating the potential for a faster and more robust fusion, ” stated the company announcement.
“We continue to stand behind our products, ” said Peter Ullrich, M.D., former surgeon and CEO of Titan Spine. “Over the last few months, we’ve received positive feedback regarding our warranty from the field and we are proud to offer it as a testament to the knowledge that our products are engineered for optimal success in patients. Ultimately, the warranty demonstrates the significant confidence we have in our products and the science validating our surface technology. On the heels of the recent FDA clearance of our TL lateral system and winning the Whitecloud Award for Best Basic Research from the Scoliosis Research Society (SRS) at IMAST 2014, we look forward to accelerating momentum by providing our physician customers an additional reason to trust that our products will successfully perform in patients.”
In addition to its Wisconsin facility, the company also has a facility in Laichingen, Germany.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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