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Reimbursement / Regulatory

icotec Gains FDA Clearance for VADERone Pedicle Screw -

icotec was granted FDA 510(k) clearance for the VADER®one pedicle screw system for both minimally invasive and open spine procedures. VADERone is manufactured from icotec's BlackArmor® Carbon/PEEK material, which comprises continuous carbon fibers combined with polyetheretherketone, produced using injection molding CFM (Composite Flow Molding) technology. The resulting 3-dimensionally reinforced, nonmetallic implants provide strength and radiolucency of particular importance in the treatment of oncology patients. BlackArmor's characteristic x-ray, CT and MRI translucency allow optimal delineation of a tumor from healthy tissue, which may in turn facilitate radiotherapy planning, improve radiosurgery treatment and allow immediate and precise monitoring of tumor recurrence. More than 10,000 BlackArmor pedicle screws have been implanted ex-U.S. (icotec AG, 7/8/19)