Orthofix International N.V., issued a news release in January announcing the company’s new anterior cervical interbody system which incorporates the benefits of PEEK with potential ingrowth from porous titanium endplates. We published the announcement shortly thereafter with a photo of the Construct Mini PEEK Titanium Spacer System being used in a multi-level case.
Clarification of Intended Use for Orthofix Spacer System
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Ted Bird, the company’s senior vice president, global marketing has asked us to publish the following clarification:
“The image of the Orthofix International N.V. Construct Mini PEEK Titanium Spacer System provided on page 18 of the volume 9, Issue 2 Newsletter that shows the Construct Mini PEEK Titanium Spacer System without supplemental fixation in a multi-level case, which is an intended use that has not been authorized for marketing in the U.S. The FDA-cleared indications for use of the Construct Mini PEEK Titanium Spacer System are for spinal fusion procedures at one level in the cervical spine, (C2-T1) in skeletally mature patients with degenerative disc disease, (DDD). The Construct Mini PEEK Titanium Spacer System is intended for use with autograft and supplemental fixation system, (i.e. anterior cervical plate).”
We appreciate the clarification.
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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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