By: 2 September 2019
icotec AG granted FDA clearance to market VADERone pedicle screw system

PROMOTIONAL FEATURE

icotec AG, a Swiss company, recently announced that the VADER®one pedicle screw system was granted US Food and Drug Administration (FDA) 510(k) clearance for both minimally-invasive and open spine surgical procedures. VADER®one, made from icotec’s unique BlackArmor® material, was designed for secure stabilisation and post-operative visualisation, which is important after spinal tumour procedures.

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-reinforced polyetheretherketone) implants hold major advantages when compared with standard titanium implants by generating significantly fewer image artifacts.” [1]

VADER®one is made from icotec’s unique 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 Moulding) manufacturing technology. This process allows for three-dimensionally reinforced, non-metallic implants providing both the strength and radiolucency needed for oncology patients and