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Instratek, a US developer of medical devices for extremity surgery, selected Solvay’s Ixef 1022 polyarylamide (PARA) resin to mould several components of its STAPiX staple fixation system used for surgical procedures on the forefoot, mid-foot, hind-foot and hand.
According to Solvay, Instratek, which just launched the STAPiX system in the US, chose Ixef PARA resin for its high strength and stiffness, excellent mouldability and attractive price point for single-use medical devices.
“Our engineers initially explored several materials for this application, including ABS and PEI, but none could match Ixef PARA’s unique combination of mechanical properties, aesthetics and manufacturability,” said Lance Terrill, Director of Engineering at Instratek. “Solvay’s hands-on technical support and expertise in medical-grade polymers were other factors that influenced our decision. The initial success of our advanced STAPiX system makes it quite clear that we made the right choice.”
Solvay explains that Ixef 1022 PARA, a 50 percent glass-filled compounded resin, is used for the staple inserter handles, which are subject to high bending stress when the device opens a superelastic nitinol staple prior to its insertion into the bone. Solvay claims that, of the polymers tested, only Ixef 1022 PARA allowed bending of the nitinol staple while minimising flexing in the tool’s handles. In fact, the flexural strength of Solvay’s material helped to reduce the size of the STAPiX spreader handles, thereby improving the experience of the surgeon and support staff in the operating room.
“Solvay’s proactive approach to designing world-class materials for single-use healthcare devices enabled Instratek to develop a leading-edge staple fixation system that raises the bar in stapler performance and reliability,” said Dane Waund, global Healthcare Market Manager for Solvay Specialty Polymers. “The STAPiX staple fixation system underscores Solvay’s deep understanding of emerging healthcare trends and our collaborative approach to delivering the materials solutions customers need to achieve their design goals, differentiate their products and grow their business.”
As with all of Solvay’s medical-grade polymers, Ixef 1022 PARA demonstrates no evidence of cytotoxicity, sensitisation, intracutaneous reactivity or acute systemic toxicity, based on biocompatibility testing as defined by ISO 10993:1. Medical-grade Ixef PARA resins are available worldwide in a broad range of gamma-stabilised colours, making them well-suited for single-use medical device applications that must maintain excellent aesthetics despite repeat sterilisation by gamma radiation or other methods, such as application of ethylene oxide.
Photo provided by Solvay.
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