Research & Development
icotec AG awarded US FDA clearance to market VADER one pedicle screw system for spinal surgeries
9 July 2019 -

Swiss spinal implant company icotec AG announced on Tuesday that it has received US Food and Drug Administration (FDA) 510(k) clearance for the VADERone pedicle screw system for both minimally-invasive and open spine surgical procedures in oncology patients.

According to the company, VADERone was designed for secure stabilisation and post-operative visualisation, which is important after spinal tumour procedures. The VADERone implants are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumours involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

VADERone is made from icotec's unique BlackArmor Carbon/PEEK material, which consists of continuous carbon fibres combined with PEEK (polyetheretherketone) and is produced using its injection molding CFM (Composite Flow Molding) manufacturing technology.

The implants made of BlackArmor are biocompatible and have been successfully implanted for over 15 years. Their X-ray, CT and MRI translucency makes a significant difference during the surgical procedure and postoperatively in assessing the site of care. In patients with spinal tumours, optimal delineation of the tumour from healthy tissue can facilitate radiotherapy planning, improve radiosurgery treatment and allow immediate and precise monitoring of possible relapses, concluded the company.



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