icotec ag Receives FDA Clearance for the VADER® Pedicle - System with Bone Cement Augmentation

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Nov 10, 2020, 07:43 ET

ALTSTAETTEN, Switzerland, Nov. 10, 2020 /PRNewswire/ -- icotec ag, the leading medical device manufacture of Carbon/PEEK spinal implants, announces the U.S. Food and Drug Administration (FDA) 510(k) clearance to market the VADER® Pedicle - System for use with bone cement for augmentation or without.

Fenestrated VADER® pedicle screw with bone cement

Lateral x-ray image of a vertebral body instrumented with VADER® pedicle screws including cement augmentation

Intra-operative AP fluoroscopy image of a cadaver specimen showing cement application during a percutaneous procedure with the VADER® pedicle system

The VADER® Pedicle System is 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 tumors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.

The system can be used by surgeons with icotec's state-of-the art standard surgical technique and has the ability to be used in either open, minimally invasive or percutaneous surgical procedures involving the thoracic or lumbar spine. The screw's fenestration allows for bone cement augmentation to increase stability in patients with compromised bone quality.

"We are so proud to present today the VADER® product family which represents our continued commitment to develop and commercialize spinal implants made from our radiotransparent, nonmetallic BlackArmor® material that produces minimal image artifact while eliminating shielding and scattering of radiation during oncology treatments," said Roger Stadler, CEO of icotec ag.

The VADER® pedicle screw 6.0 is manufactured with BlackArmor®, a Carbon/PEEK material, and Ti-iT® pure titanium coating on the screw shaft. -The radio-transparency of the VADER® pedicle screw 6.0 assists in the planning, application, and follow-up care of radiotherapy 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 nonmetallic spinal implants made from BlackArmor®. icotec's proprietary BlackArmor® material is made up of continuous carbon fibers combined with polyether ether ketone (PEEK) and is manufactured with icotec's unique injection moulding CFM (composite flow molding) manufacturing technology. With over 15 years of clinical success and more than 40,000 implanted products made from the unique BlackArmor® material, icotec ag is the leading provider of Carbon/PEEK spinal implants.

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

SOURCE icotec ag