Titan Spine said yesterday it is expanding its spinal device warranty to include free replacement if its Endoskeleton interbody fusion devices delaminate or generate particulate debris during implantation.

The Mequon, Wisc.-based company said it amended its warranty, which it launched in 2014, based on its “confidence in its proprietary subtractive manufacturing process.

“Since we 1st 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 study 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,” CEO Dr. Peter Ullrich said in a press release.

A study recently published in The Spine Journal indicated that the company’s Endoskeleton titanium interbody fusion devices generated no particulate debrish or delamination during a simulated impaction to the disc space, Titan Spine said.

“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,” prez Kevin Gemas said in prepared remarks

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