2017-01-27: VADER® and LightMore®: Pedicle Screw Systems made from BlackArmor® Carbon/PEEK material

ADER® and LightMore®
Pedicle Screw Systems

The aging population and the increasing healthcare cost are one of the hot topics in spine surgery. In order to find a better answer to such trends/challenges, icotec broadens its product portfolio with two new pedicle screw families, both exclusively made from BlackArmor® Carbon/PEEK biomaterial.

Both pedicle screw systems rely on proven surgical techniques and utilise design elements found in state-of-the-art pedicle screw systems. Their core value features high strength BlackArmor® Carbon/PEEK material and is a true alternative to metal implants.

BlackArmor® is 100 per cent radiolucent in all state-of-the-art imaging modes (MRI, CT and X-ray) and prevents imaging artifacts; a significant clinical benefit in the postoperative monitoring of anatomical structures. In addition, the non-metallic nature of the BlackArmor® material minimizes the risk for patients where metal allergies are a potential concern.

With a clinical track record of > 15 years and more than 20,000 implantations of BlackArmor® material since the year 2000, icotec has become the world leader for medical Carbon/PEEK implants. BlackArmor® Carbon/PEEK material is the result of a unique combination of continuous, high strength carbon fibers in a PEEK polymer matrix and icotec’s injection moulding CFM process. The result is implants with interwoven 3D fiber architecture/alignment that provide an unmatched combination of strength and endurance. Such a technology is the enabler for complex designed implants such as pedicle screws, vertebral body replacement devices or supplemental fixations devices, e.g. anatomical bone plates. The combination of mechanical strength and non-metallic properties make BlackArmor® also ideally suited for radiation therapy of spinal tumours and the subsequent follow up controls.

Comparison of implant artifact in cadaveric model; left: significant artifacts caused by titanium pedicle screw; right: minimal artifacts with BlackArmor® pedicle screw

Before administering radiation therapy, the radiologist relies on accurate CT images to plan the correct radiation dose. However, the presence of metal spinal implants causes significant artifact on the planning images. This artifact makes it more difficult – sometimes almost impossible – to delineate the tumour from healthy anatomic structures and organs at risk and correctly calculate the proper dose distributions.

During radiation therapy, metal spinal implants may also shield tumour cells from the radiation. In addition, metal components induce scattering of the radiation beams into the surrounding healthy soft tissue potentially causing adverse side effects. And in some cases, patients for proton therapy are not eligible for the treatment since proton radiation therapy requires the absence of metals.

An in vitro study by Kashua (2016) compared spinal constructs made from titanium vs. BlackArmor® material in a radiation-oncology setup. The group found significantly reduced artefacts for BlackArmor® material which resulted in a more accurate and homogenous dose planning.

Clinical experiences with BlackArmor® Carbon/PEEK pedicle screws in spinal tumour surgery have been published by Eicker et al, 2014 and 2016 and Süss et al 2014. Both groups confirmed simplified and better dose-planning and radiation therapy with BlackArmor® implants.

The VADER® pedicle screw system unites a sophisticated set of features and benefits to provide the surgeon with great flexibility in the surgical treatment using only one pedicle screw design. Fenestrations in the screw tip enable cement augmentation in cases where additional fixation is desired. A self-tapping tip allows direct screw insertion without additional pre-tapping. The cannulation enables guided insertion via a K-wire in open surgery and makes the screw MIS ready.

The LightMore® pedicle screw family comprises essential features of modern pedicle screw systems for open surgery. A solid, self-cutting screw in a variety of diameters and lengths, combined with a straightforward and streamlined instruments set, provides an appealing cost/benefit ratio.