Emerging Implant Technologies on target with disruptive spinal implant designs

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This article is sponsored by EIT, LLC.

Emerging Implant Technologies (EIT): Cellular Titanium® for improved fusion results

Frustration at the clinical shortcomings of existing cage designs and materials on the market provided the impetus for the creation of EIT Cellular Titanium®. Previous market solutions were inappropriate for fusion, and had issues of biocompatibility, subsidence, migration and imaging distortion.

To improve in all of these areas, a proven, bonefriendly material in a specific configuration was needed and EIT Cellular Titanium® was developed. It is a porous titanium structure, optimally designed according to scientific insights on ideal pore shape, pore size and porosity to optimise bone ingrowth.

Due to the availability of Selective Laser Melting (SLM) technology including (proprietary) post-processing methods, it has been possible to create a highly porous, osteo-influential titanium scaffold for osseointegration, which also ensures uncompromised imaging on X-ray and MRI with excellent follow up on CT scans to define bone ingrowth and fusion. The EIT Cellular Titanium® structure is included in all of EIT’s implant designs.

Proof
Over 15,000 cases worldwide have been performed, including Cervical, PLIF, TLIF and ALIF procedures, without any reporting of implant breakages or implant related technical issues. Various clinical case studies have shown rapid bony fusion with the EIT implants, especially when compared to PEEK cages with autograft.

The preliminary evaluation of the EFFECT trial (stand-alone EIT cervical implant, N=10 with three and 12 months Functional X-ray Analysis (FXA)) has shown some very promising results. The EIT cervical implants demonstrated a fusion rate of 90% after 12 months, without any addition of bone-graft, biomaterial or supplemental fixation. Currently, the final results of the total patient cohort (N=50) are being evaluated, and both radiologically and clinically, the EIT cervical implants seem to surpass cervical PEEK implants with autograft outcome.

A great example of the bone-incorporative capacity of the EIT implants is the retrieval
histology of an EIT cervical implant, two years postoperatively. Extensive bone ingrowth endplate-to-endplate (five mm height) indicates mechanical loading throughout the titanium implant without stress shielding, and mature lamellar bone and healthy bone marrow in direct contact with the titanium scaffold is proof that the EIT implants act as a titanium bone graft.

Cost-effectiveness
EIT created implants that addressed the shortcomings of current products available on the market without adding costs, and without the need for special coatings or bone grafts. However, for US entry, the Food and Drug Administration (FDA) regulation require a bone
graft window in all spinal fusion implants. Therefore, EIT had to redesign their whole implant line and now offers two lines of first generation implants.

The EIT Cellular Titanium® implant line attained 510(k) approval in July 2017. The subsequent first successful cases in the US, combined with increasing proof of concept regarding the EIT implants internationally, has led the significance and necessity of a graft window in such spinal fusion implants to be questioned.

Towards the end of 2017, EIT successfully completed the contracting process with HealthTrust, related to an HCA (Homes and Communities Agency) contract.

As it is EIT’s goal to improve spinal care using the advantages of 3D printing technology, and to simultaneously cope with given pricing and reimbursement structures, EIT plan, together with HCA leadership, to better understand the economic impact this novel technology can have on fusion rates, implant costs and the possible avoidance of
high cost osteobiologics when getting approval for the international implant versions in the US. Study activities in this line have been put into action.

Next-Gen EIT implant with integrated functionality first worldwide
The competitive advantage of the first generation of EIT implants is the ability to market this superior implant performance for a better price. The second generation of products with integrated 3D printing functionality, which are patent protected, will go a
step further.

The adjustable EIT PLIF cage, which got CE mark approval in January 2018, is printed as one piece with no assembly needed in the production process. This reduces cost significantly compared to regular expandable cages that are manufactured with traditional machining processes. It is the first fully 3D printed adjustable interbody fusion cage worldwide.

The goal with the EIT PLIF adjustable is to reduce intraoperative trauma, optimise size adaptation, improve restoration of spinal balance and, together with the EIT Cellular Titanium® porous structure, to enhance primary stability and bony integration. Ultimately, these work to improve fusion rates.

Adjustable cage technology has the potential to change the interbody fusion cage market as it can be offered at reasonable prices that cope with existing pressure and reimbursement systems all over the globe.

The first cases have already been performed and the intuitive instrumentation together
with the functionality of the implant enabled a straightforward procedure resulting in an excellent postoperative result.

Next in the EIT ‘functional’ research and development pipeline are stunning lumbar implants enclosing ‘mind-breaking’ concepts and design features. More information soon to come.

W: www.eit-spine.de

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