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 News Release - November 10, 2020

icotec ag Receives FDA Clearance for the VADER(R) Pedicle - System with Bone Cement Augmentation

ALTSTAETTEN, Switzerland, Nov. 10, 2020 -- (Healthcare Sales & Marketing Network) -- 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 VADERŪ Pedicle - System for use with bone cement for augmentation or without.

The VADERŪ 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 VADERŪ product family which represents our continued commitment to develop and commercialize spinal implants made from our radiotransparent, nonmetallic BlackArmorŪ material that produces minimal image artifact while eliminating shielding and scattering of radiation during oncology treatments," said Roger Stadler, CEO of icotec ag.

The VADERŪ pedicle screw 6.0 is manufactured with BlackArmorŪ, a Carbon/PEEK material, and Ti-iTŪ pure titanium coating on the screw shaft. -The radio-transparency of the VADERŪ 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 BlackArmorŪ. icotec's proprietary BlackArmorŪ 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 BlackArmorŪ material, icotec ag is the leading provider of Carbon/PEEK spinal implants.

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


Source: icotec

Issuer of this News Release is solely responsible for its content.
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