German medical device manufacturer Emerging Implant Technologies received 510(k) approval from the FDA to commercialize its spinal interbody products for anterior lumbar interbody fusion, transforaminal lumbar interbody fusion, posterior lumbar interbody fusion and cervical procedures.
Here are six things to know:
1. Founded in 2014, EIT is the first medical device manufacturer to specialize on implants for spinal alignment, which are designed according to science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods.
2. The EIT implants are made of EIT Cellular Titanium, which is designed to address the shortcomings of current cage designs and materials, including non-fusion, biocompatibility, subsidence, migration and imaging distortion.
3. EIT Cellular Titanium is a porous titanium structure designed with the use of metal 3D-printing selective laser melting technology and proprietary post-processing methods to create an osteo-influential scaffold for osseointegration.
4. The implants have a porosity of 80 percent, and the highly porous scaffold is designed to ensure extensive bone ingrowth due to its elasticity close to the cancellous bone.
5. 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 show extensive bone ingrowth throughout the total implants in the cervical and lumbar spine in a short timeframe.
6. The implants have been used in over 10,000 cases spanning more than 15 countries including Germany, France, Australia, Korea and the Netherlands.
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