Medical device company Instratek (Houston, TX) has selected a polyarylamide (PARA) resin from Solvay Specialty Polymers (Alpharetta, GA) to mold several components of its Stapix staple-fixation system, Solvay announced today. The Stapix system, which was just launched in the United States, is used for surgical procedures involving the feet and hands. Solvay's Ixef 1022 PARA resin was chosen over other polymers because of its strength and stiffness, moldability and price point, according to the thermoplastics supplier.
"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, particularly its superior flexural stiffness," said Lance Terrill, Director of Engineering at Instratek in a prepared statement. He also lauded Solvay's technical support and expertise in medical-grade polymers.
A 50% glass-filled compounded resin, the Ixef 1022 material is used for the staple inserter handles, which are subject to high bending stress when the device opens a super-elastic nitinol staple prior to its insertion into the bone. It achieved optimal minimized flexing in the tool's handles while bending the nitinol staple compared with other polymers that were tested.
As with all of Solvay's medical-grade polymers, Ixef 1022 PARA demonstrates no evidence of cytotoxicity, sensitization, intra-cutaneous 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 range of gamma-stabilized colors, making them well-suited for single-use medical device applications that must maintain excellent aesthetics despite sterilization by gamma, ethylene oxide and other methods.