Swiss medical device manufacturer icotec has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its VADER pedicle system for use with bone cement for augmentation or without.
The company has developed a VADER pedicle system to restore the integrity of the spinal column even in the absence of fusion for a limited time period.
The system is suitable for patients with advanced-stage tumours involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, said the company.
icotec’s advanced surgical technique enables surgeons to use the VADER pedicle system. It can be used either in open, minimally invasive or percutaneous surgical procedures involving the thoracic or lumbar spine.
The fenestration of the screw facilitates bone cement augmentation to enhance stability in patients with compromised bone quality.
BlackArmor, a carbon/PEEK material, is used to manufacture the VADER pedicle screw 6.0. The screw shaft features Ti-iT pure titanium coating.
According to the company, the radio-transparency of the VADER pedicle screw 6.0 helps in the planning, application, and follow-up care of radiotherapy for patients with spinal tumours.
icotec CEO Roger Stadler said: “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.”
In June this year, icotec secured FDA 510(k) clearance and CE mark approval for KONG-TL and KONG-C vertebral body replacement systems.
Established in 1999, icotec is engaged in the development, manufacturing and distribution of nonmetallic spinal implants.
