The spinal cord dura mater reaction to nitinol and titanium alloy particles: a 1-year study in rabbits.

This investigation was undertaken to simulate in an animal model the particles released from a porous nitinol interbody fusion device and to evaluate its consequences on the dura mater, spinal cord and nerve roots, lymph nodes (abdominal para-aortic), and organs (kidneys, spleen, pancreas, liver, and lungs). Our objective was to evaluate the compatibility of the nitinol particles with the dura mater in comparison with titanium alloy. In spite of the great use of metallic devices in spine surgery, the proximity of the spinal cord to the devices raised concerns about the effect of the metal debris that might be released onto the neural tissue.

In vivo biocompatibility testing of peek polymer for a spinal implant system: a study in rabbits.

We are developing a new spinal implant system (SIS) without fusion (bone graft). This SIS is made from two materials, metal and polyetheretherketone (PEEK) polymer. The Food and Drug Administration recommended testing in vivo, in an animal model, whether the PEEK polymer could be used in a SIS without any harm of wear debris to the nervous tissue (spinal cord and nerve roots).