02 October 2018
02 October 2018
Solvay's Ixef polyarylamide (PARA) resin has helped enable a new single-use instrument kit for anterior cervical fusion procedures developed by Intelligent Implant Systems. The MEDIANT Anterior Cervical Plating System leverages Solvay’s compound to help boost operating room efficiency, eliminate onsite sterile processing and reduce infection risk.
“The primary benefit of Solvay’s Ixef PARA in this application is its metal-like strength, which gives our single-use surgical instruments a very high level of performance without incurring the costs associated with machining metal and repeated steam sterilisation,” says Marc Richelsoph, President and CEO of Intelligent Implant Systems, Charlotte, North Carolina, US. “Although PEI also offered viable options for our surgical tool kit, we specified Ixef GS-1022 PARA because its superior stiffness and mouldability was essential for the kit’s instruments.”
Ixef GS-1022 PARA, containing 50% glass fibre reinforcement, forms the awl and pin-screwdriver handles, measuring caliper and locking plier handles in Intelligent Implant Systems’ kit. The polymer’s excellent impact resistance also eliminated the need for a metal strike plate that had been part of the awl’s early designs. This reduced the cost and simplified the manufacture and assembly of the instrument, further supporting the economics of single-use instruments.
Ixef GS-1022 PARA is said to provide excellent aesthetics, including an attractive surface finish. The material is available in a range of gamma-stabilised colours, including the signature green of the MEDIANT System’s tools. Together, these properties ensure Intelligent Implant Systems’ single-use instruments retain their visual appeal after they are gamma sterilised and packaged for delivery. Solvay's polymer has been evaluated for ISO 10993 limited duration biocompatibility and is supported by an FDA Master Access File, which helped streamline the MEDIANT kit’s navigation through regulatory approvals.
“Solvay was an early advocate of the healthcare industry’s shift toward single-use surgical instruments, and we sought to support customers by proactively developing a broad portfolio of biocompatible polymer alternatives to metal – complete with gamma-sterilised colours and master access files,” reports Jeff Hrivnak, Business Manager for Healthcare at Solvay’s Specialty Polymers Global Business Unit. “Yet while the industry’s growing adoption of our advanced polymers validates this early insight, we derive much greater satisfaction in working closely with innovators like Intelligent Implant Systems to help achieve unique new designs for improving patient results.”
Photo provided by Solvay
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