Emerging Implant Technologies GmbH (EIT), a medical device manufacturer based in Wurmlingen, Germany, announced that it has received clearance from the FDA to commercialize its spinal interbody product offerings for anterior lumbar interbody fusion (ALIF), transforaminal lumbar interbody fusion (TLIF), posterior lumbar interbody fusion (PLIF) and cervical procedures.
FDA Clears Novel German ALIF, PLIF and TLIF Implants
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The novel aspect of the company’s offerings is its EIT Cellular Titanium structure. As the company wrote in its July 18, 2017 news release, “EIT Cellular Titanium is a porous titanium structure that has been designed according to scientific insights on ideal pore shape and size to optimize bone ingrowth.”
“Due to the availability of metal 3D printing Selective Laser Melting (SLM) technology and proprietary post-processing methods, it has been possible to create a highly porous, osteo-influential titanium scaffold for osseointegration.”
“This EIT Cellular Titanium structure has been applied in the complete ALIF, TLIF, PLIF and cervical implant line, and clinical case studies and retrieval analysis demonstrate extensive bone ingrowth throughout the total implants in the cervical and lumbar spine in a short time frame.”
“EIT Cellular Titanium Interbody cages target for Smart Spinal Fusion in combining an osteo influential scaffold with designs to address spinal alignment. The implants have been used in over 10,000 cases in over 15 countries including Germany, France, Australia, Korea and the Netherlands. With the milestone of this 510(k) approval [sic], EIT is moving towards full commercialization effective immediately.”
Guntmar Eisen, co-founder and CEO for EIT, told OTW, “The FDA process went smoothly—we filed the entire portfolio in one application. We will be in all major markets leading the market of 3D printed cages. We will be combining EIT cellular titanium technology with functionality—fully printed functional spinal cages, eliminating the need of combining materials and assembly processes—functional cages based on our IP platform of 3D printed functional spinal implants (MIS, expansion, distraction, sagittal balance correction, coronal plane correction etc.…).”
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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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