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 the results of the EFFECT trial have been presented at the SSA 2018 meeting in Adelaide.
The EFFECT Trial is a prospective controlled trial, evaluating the clinical and quantitative radiological results of 50 patients, who received a single level stand-alone EIT Cervical Implant with no addition of biologics and no use of a plate or screw-fixation. The 3, 6 month and 1-year results have been compared to historical data of a cohort of patients with single level stand-alone PEEK cages with autograft (acknowledged as the ‘golden standard’) that evaluated the exact same outcome parameters.
All clinical parameters (NDI, VAS neck, vas arm, EQ5D) improved significantly at 3 months follow up, with a slight improvement further over time. The results did not differ from the clinical outcome in the PEEK-autograft cohort.
That the EIT cervical implant warrants an excellent primary stability without additional fixation could be observed from the significant decline of the mean Range of Motion (RoM) from 8,7° pre-operatively to 2,5° after 3 months in the EIT group, whereas this remained 3,4° in the PEEK-autograft group. The decline of the RoM measured with validated software on functional X-rays over time was chosen as an objective criteria for the quality and speed of fusion. In calculating the fusion rate (< 2° angular motion), the EIT group outperformed the PEEK-autograft group at every time frame.
“This study has objectified our experience with the international version of the EIT Cervical Implant, that has no graft hole window. Without the need for adding biomaterials or supplemental fixation we get favorable clinical and fusion results, which is also very interesting from a cost perspective”, said Jasper Wolfs, M.D., Neurosurgeon at the Medical Center Haaglanden, The Hague, Netherlands.
Although the EIT implant is made of titanium, the 3D-printed scaffold with 80% porosity, warrants a more ‘elastic’ biomechanical behavior. This was also reflected in the subsidence rate, which was lower for the EIT Cervical Implant compared to the PEEK cage.
“Frustration at the clinical shortcomings of existing cage designs and materials on the
market provided the impetus for the creation of EIT Cellular Titanium®”, says Nancy Lamerigts, M.D., Ph.D., VP research and marketing of EIT: “Previous market solutions had issues in either one or more of the areas of fusion, biocompatibility, subsidence, migration and imaging distortion. The results of the EFFECT trial objectify that we are able to tackle all areas for the better and significantly add value to the patients, surgeons and payers”.
EIT is the first medical device manufacturer to exclusively focus on spinal implants, that are designed according to latest science on optimal bone ingrowth in porous titanium scaffolds and produced with additive manufacturing methods. EIT was founded in 2014. Implants and Instruments are made in Germany.
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 EIT 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 15.000 EIT cases have been performed in over 15 markets globally. EIT received various FDA approvals and began introducing products in the US in Q4 of 2017.