ALTSTAETTEN, Switzerland, Jan. 24, 2023 /PRNewswire/ — icotec ag, the main medical system producer of Carbon/PEEK spinal implants, pronounces the U.S. Food and Drug Administration (FDA) 510(ok) clearance to market the VADER® Pedicle System inclusive of Ø 4.5 mm pedicle screws and prolonged lengthy Carbon/PEEK rods comprised of BlackArmor®.
The prolonged VADER® Pedicle System maintains its confirmed indication and flexibility for open, MIS and cement-augmented surgical methods whereas offering further choices for stabilizing the upper-thoracic area of the spine.
“60% of metastatic tumors happen within the thoracic spine1“. We’re extraordinarily proud that icotec is the world-leading supplier of prolonged options for the stabilization of this incessantly affected spinal area with the extension of its VADER® product household with canulated and fenestrated Ø 4.5 mm pedicle screws and longer rod choices. An essential milestone that represents our continued dedication to develop and commercialize spinal implants comprised of radiolucent BlackArmor®, increasing remedy choices and permitting for safer tumor care,” mentioned Roger Stadler, CEO of icotec ag.
Radiolucent BlackArmor® implants broaden therapeutic choices for sufferers 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 seven.5 mm in lengths of 25 to 60 mm, and rods in numerous shapes as much as 300 mm in size. VADER® screws and rods are product of distinctive BlackArmor® Carbon/PEEK composite materials. BlackArmor® gives glorious stabilization of the spine whereas being fully radiolucent, permitting for clear visualization in postoperative imaging, improved radiation planning and dose supply, and increasing remedy choices for sufferers with spinal tumors.
About icotec ag
Based in 1999, icotec ag is a family-owned SME primarily based in Altstaetten, Switzerland. icotec develops, manufactures, and distributes spinal implants comprised of radiolucent and artifact-free BlackArmor®. icotec’s proprietary BlackArmor® materials is made up of steady carbon fibers mixed with PEEK and is processed with icotec’s distinctive manufacturing know-how. With 20 years of scientific success and greater than 50,000 implanted merchandise, icotec ag is a pioneer in cutting-edge spinal tumor remedy.
For additional data, go to our web site (www.icotec-medical.com)
1Wewel JT, O’Toole JE: Epidemiology of Spinal Twine and Column Tumors. Neurooncol Pract. 2020 Nov 18;7(Suppl 1):i5-i9. doi: 10.1093/nop/npaa046. PMID: 33299568; PMCID: PMC7705531.