Solvay’s polyarylamide resin stands up to stiff challenges in single-use bone-fixation device
In developing a more robust, single-use bone-fixation system than currently available devices, MedTech startup Reign Medical (Tulsa, OK) went on the hunt for a biocompatible material with exceptional stiffness properties. A polyarylamide (PARA) resin from Solvay (Alpharetta, GA) stood out and is used to mold several components of the medical device soon to be on the market.
The Clench compression staple system comprises a disposable sterile surgical toolset for fixating hand and foot bone fragments and performing related procedures. A patented threaded hub allows surgeons to incrementally expand the implant for proper insertion while retaining the mechanical properties of the nitinol staples for continuous compression across the fusion site after implantation. Reign Medical specified Solvay’s Ixef GS-1022 PARA, a 50% glass-fiber-reinforced grade, for the device’s implant sizer, drill guide and each part of the implant delivery instrument, including its handle, the saddle on which the staple sits and the threaded compressor that forces the staples fully open, said Solvay in a press release.
A high-stiffness material was required for this application because of the mechanical strain that the components experience. Offering metal-like strength, rigidity, and dimensional stability, the biocompatible Ixef PARA polymer also provides an exceptional surface finish, according to Solvay. Available in a range of gamma-stabilized colors, Ixef PARA is optimized for sterilization using high-energy gamma radiation, showing no significant change in appearance or performance after sterilization. The material has been evaluated for ISO 10993 limited-duration biocompatibility and is supported by an FDA Master Access File.
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