The extended VADER Pedicle System maintains its proven indication and versatility for open, MIS and cement-augmented surgical techniques while providing additional options for stabilizing the upper-thoracic region of the spine
icotec ag, the leading medical device manufacturer of Carbon/PEEK spinal implants, announces the U.S. Food and Drug Administration (FDA) 510(k) clearance to market the VADER Pedicle System inclusive of Ø 4.5 mm pedicle screws and extended long Carbon/PEEK rods made from BlackArmor.
The extended VADER Pedicle System maintains its proven indication and versatility for open, MIS and cement-augmented surgical techniques while providing additional options for stabilizing the upper-thoracic region of the spine.
“60% of metastatic tumors occur in the thoracic spine1″. We are extremely proud that icotec is the world-leading provider of extended solutions for the stabilization of this frequently affected spinal region with the extension of its VADER product family with canulated and fenestrated Ø 4.5 mm pedicle screws and longer rod options. An important milestone that represents our continued commitment to develop and commercialize spinal implants made from radiolucent BlackArmor, expanding treatment options and allowing for safer tumor care,” said Roger Stadler, CEO of icotec ag.
Radiolucent BlackArmor implants broaden therapeutic options for patients with spinal tumors. Lateral x-ray of the thoracic spine, stabilized with VADER Pedicle System – courtesy of Naresh Kumar, Singapore.
The VADER Pedicle System is now consisting of pedicle screws of diameters between 4.5 and 7.5 mm in lengths of 25 to 60 mm, and rods in different shapes up to 300 mm in length. VADER screws and rods are made of unique BlackArmor Carbon/PEEK composite material. BlackArmor offers excellent stabilization of the spine while being completely radiolucent, allowing for clear visualization in postoperative imaging, improved radiation planning and dose delivery, and expanding treatment options for patients with spinal tumors.
Source: Company Press Release