The Swiss maker of carbon fiber-reinforced polymer spine devices, icotec ag, recently announced that the FDA and EU Regulatory Authorities have cleared for commercialization a pair of vertebral body replacement devices.
FDA and EU Clears Carbon Fiber VBRs
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The devices, the KONG®-C for cervical and KONG®-TL for thoracolumbar, are intended to stabilize the spine after removal of all or part of one or more vertebral bodies due to trauma, or tumor resection. The implants are made with the company’s BlackArmor, a carbon fiber-reinforced PEEK polymer, and a textured titanium coating called Ti-iT®. The incorporation of carbon fiber in PEEK allows the company to optimize the strength and stiffness of the devices.
The devices are modular, allowing surgeons to customize endplate fit and lordosis correction. Additionally, the KONG-TL is expandable and the Kong-C implant body itself is curved to provide lordosis. The indications for the devices require supplemental fixation, but due to the common use in terminal cancer patients, the devices are not intended to result in fusion in all cases.
Another major benefit of the material is the radiolucency, which not only helps visualization, which is critical in tracking the re-growth of tumors, but also does not interfere with the planning of radiotherapy. Previously, patients requiring spine stabilization could not be properly cared for until after radiotherapy due to the use of metal pedicle screws and implants.
icotec ag CEO Roger Stadler was unsurprisingly excited about this announcement. He expects that the clearances will allow for “the imminent market launch of the KONG®-TL/C vertebral body replacement systems in Europe and the US… These systems perfectly complement the icotec ag pedicle screw systems already in surgical use.”
The company claims over 15 years of clinical success and more than 40,000 BlackArmor implants have been used worldwide. The company’s lumbar pedicle screw and rod system, VADER®one, received 510(k) clearance in May 2020. The company, however, does not offer a cervical spine fixation solution.
Another company that specializes in carbon fiber implants, Israel-based CarboFix, received 510(k) clearance in June 2020 for a cervical plate that may potentially work to provide an all-carbon fiber cervical solution when it becomes available.
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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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