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FDA clearance for ETurn lumbar spacer & CE-Approval for icotec pedicle screw system

News International-French

17 Aug 2011

icotec is pleased to announce that FDA clearance has been received for the continuous CF/PEEK Lumbar Spacer "ETurn" for commercial sale and distribution in the US and that CE approval was given for its pedicle screw system with CF/PEEK rods.

 

 

icotec is pleased to announce that FDA clearance has been received for the continuous CF/PEEK Lumbar Spacer "ETurn" for commercial sale and distribution in the US and that CE approval was given for its pedicle screw system with CF/PEEK rods.

ETurn lumbar spacer

In July 2011 icotec received FDA clearance for its ETurn lumbar spacer. This implant is used as an intervertebral body fusion device (IBF) for posterior intersomatic spondylodesis (PLIF, TLIF and EPLIF). The ETurn Lumbar Spacer is a lumbar fusion device manufactuerd from continuous carbon fibre reinforced PEEK (CF/PEEK).

The ETurn lumbar spacer was developed with Professor Fritz Magerl: "The ETurn Lumbar Spacer has a unique guiding surface. Surgeons using this implant are very much in favor of the self-positioning features of the implant. These features improve the surgical technique and may reduce risk of failures"

icotec pedicle screw system with CF/PEEK rods

The icotec pedicle screw system is now CE approved. The icotec system combines traditional polyaxial Ti alloy screws with Carbon Fibre reinforced PEEK (CF/PEEK) rods. icotec sees a number of advantages for this system. Using the CF/PEEK rods, the pedicle screw system shows better mechanical fatigue properties than titanium rods with the same diameter. At the same time, the CF/PEEK rod system is less rigid.

The fully radiolucent CF/PEEK rods allow for optimal visualization in imaging procedures.

The introduction of the system with CF/PEEK rods is just the first step towards introducing a fully composite pedicle screw system. Screw shaft and tulip development are currently ongoing.

icotec ag: A leading medical composite company

icotec is an innovative Swiss company for continuous carbon fibre composite implants. ico-tec develops, produces and markets implants and instruments for orthopedic applications including spine and trauma.

The company has a dual strategy: icotec has positioned itself as a development partner for customized implants for companies in the orthopedic, trauma and spine market and, on the other side uses its unique resources and experiences to develop its own distinguished line of spinal and traumatology implants.

For these spinal implants icotec is expanding its own distributor network.