icotec ag Receives FDA Clearance for the Ø 4.5mm VADER® Pedicle Screws

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Jan 24, 2023, 08:05 ET

ALTSTAETTEN, Switzerland, Jan. 24, 2023 /PRNewswire/ -- 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.

icotec expands its VADER® Pedicle System with the world’s first Ø 4.5 mm Carbon/PEEK screw and extended rod portfolio in the US market, allowing more patients access to optimal spine tumor treatment.

"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.

About icotec ag

Founded in 1999, icotec ag is a family-owned SME based in Altstaetten, Switzerland. icotec develops, manufactures, and distributes spinal implants made from radiolucent and artifact-free BlackArmor®. icotec's proprietary BlackArmor® material is made up of continuous carbon fibers combined with PEEK and is processed with icotec's unique manufacturing technology. With 20 years of clinical success and more than 50,000 implanted products, icotec ag is a pioneer in cutting-edge spinal tumor therapy.

For further information, visit our website (www.icotec-medical.com)

¹Wewel 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.

SOURCE icotec ag