icotec has been granted US Food and Drug Administration (FDA) 510(k) clearance to market its VADER pedicle system inclusive of Ø 4.5mm pedicle screws and extended long carbon/polyetheretherketone (PEEK) rods made from BlackArmor.
The extended VADER pedicle system maintains its proven indication and versatility for open, minimally invasive and cement-augmented surgical techniques while providing additional options for stabilising the upper-thoracic region of the spine, say the company.
Roger Stadler, CEO of icotec, said: “Sixty percent of metastatic tumours occur in the thoracic spine1. We are extremely proud that icotec is the world-leading provider of extended solutions for the stabilisation of this frequently affected spinal region with the extension of its VADER product family with cannulated and fenestrated Ø 4.5mm pedicle screws and longer rod options. An important milestone that represents our continued commitment to develop and commercialise spinal implants made from radiolucent BlackArmor, expanding treatment options and allowing for safer tumour care.”
1. Wewel JT, O’Toole JE: Epidemiology of Spinal Cord and Column Tumors. Neurooncol Pract. 2020 Nov 18;7(Suppl 1):i5-i9. doi: 10.1093/nop/npaa046. PMID: 33299568; PMCID: PMC7705531.