Icotec earns FDA clearance for pedicle screw system

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VADERone
Icotec’s VADERone pedicle screw system

The US Food and Drug Administration (FDA) has granted Swiss devicemaker Icotec 510(k) clearance for its VADERone pedicle screw system, used for minimally-invasive and open spine surgeries.

The device uses the company’s BlackArmor carbon/PEEK composite material, a carbon fibre interwoven 3D fibre architecture to secure stabilisation and visualisation after the operation, an important aspect of spinal tumour procedures.

The nonmetallic screw system provides strength and radiolucency. The system’s X-ray, CT and MRI translucency makes a significant difference during surgery and in postoperative assessments.

In a recent publication, the neurosurgery and radiation oncology group from Technical University of Munich, Germany, stated: “In terms of postoperative evaluation of residual or recurrent tumour within the periphery of the spinal canal and column and for accurate radiation planning, CFRP [carbon fibre-inforced polyetheretherketone] implants hold major advantages when compared with standard titanium implants by generating significantly fewer image artifacts.”1

VADERone is made from Icotec’s BlackArmor Carbon/PEEK material, which consists of continuous carbon fibres combined with PEEK (polyetheretherketone), and is produced using Icotec’s injection moulding CFM (Composite Flow Molding) manufacturing technology. This process allows for 3-dimensionally reinforced, nonmetallic implants providing both, the strength and radiolucency needed for oncology patients and their treatment.

Icotec is the only company manufacturing spinal implants made of radiolucent BlackArmor Carbon/PEEK composite material. Implants made of BlackArmor are biocompatible and have been successfully implanted for over 15 years. Their X-ray, CT and MRI translucency makes a significant difference during the surgical procedure, and postoperatively in assessing the site of care.

In patients with spinal tumours, optimal delineation of the tumour from healthy tissue can facilitate radiotherapy planning, improve radiosurgery treatment and allow immediate and precise monitoring of possible relapses (tumour recurrence).

The VADERone implants are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumours involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

References

  1. Ringel F, et al. Radiolucent carbon-fibre reinforced pedicle screws for the treatment of spinal tumors: Advantages for radiation planning and follow-up imaging. World Neurosurg, 2017.

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