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Icotec Receive FDA Clearance for ETurn lumbar spacer & CE-Approval for Pedicle Screw System

09 August 2011

Icotec has received FDA clearance 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 explain that the ETurn lumbar spacer 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 manufactured 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 favour of the self-positioning features of the implant. These features improve the surgical technique and may reduce risk of failures”.

Their pedicle screw system is now CE approved and they say that the 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, also the CF/PEEK rod system is less rigid.

Icotec add that the fully radiolucent CF/PEEK rods allow for optimal visualisation in imaging procedures and the introduction of the system with CF/PEEK rods is just the first step towards introducing a fully composite pedicle screw system.