EIT Emerging Implant Technologies Announces 510(k) Approval from the FDA for Full 3D Printed Cage Portfolio
August 25, 2017 at 5:32 pm
Emerging Implant Technologies GmbH (EIT), a German medical device manufacturer exclusively focused on creating innovative technologies for spinal application by utilizing additive manufacturing, announces that it has received full approval from the FDA to commercialize its spinal interbody product offerings for ALIF, TLIF, PLIF and Cervical procedures.
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, EIT is moving towards full commercialization effective immediately.
Guntmar Eisen, Co-Founder and CEO for EIT says “This is a major milestone for EIT. We look forward to bringing our unique technologies to the United States and partnering with top tier surgeons and institutions to bring the best results to patients that are in need of these devices.”
EIT is the first medical device manufacturer to exclusively focus on implants for spinal alignment, that are designed according to latest published science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods. EIT was founded in 2014 by Hans Eekhof and Guntmar Eisen.
The EIT implants are made of EIT Cellular Titanium®, that addresses the clinical shortcomings of the current cage designs and materials (non-fusion, biocompatibility, subsidence, migration and imaging distortion), thereby obtaining very promising fusion results and improved clinical outcome due to the qualities of the porous 3-D printing of titanium. The highly porous titanium scaffold ensures extensive bone ingrowth as a result of its specific design and elasticity close to the cancellous bone. Due to its unique design with a porosity of 80% the EIT implants ensure uncompromised imaging on X-ray and MRI and enabling excellent follow up on defining bone ingrowth and fusion with CT.
A complete portfolio of Smart Spinal Implants™ based on EIT Cellular Titanium® is available for the cervical and lumbar spine, with an extensive choice in footprint sizes, heights and lordosis angles to support the recreation of sagittal balance and alignment. Since 2014 over 10.000 EIT cases have been performed in over 15 markets globally.