Specialty Polymers for Surgical Devices
Radel® PPSU (polyphenylsulfone) is the highest performing sulfone polymer of its class, as it provides unparalleled strength, exceptional chemical resistance and outstanding mechanical performance. This amorphous thermoplastic is compatible with repeat-cycle steam sterilization because of its high temperature tolerance and excellent hydrolytic stability for plastic surgical instruments. Radel® PPSU maintains its properties through 1,000 cycles of steam autoclaving and supports a variety of cleaning and disinfection techniques. Solvay tests this specialty polymer under USP Class VI testing to ensure its ability to maintain properties following gamma sterilization. Radel® PPSU is available in glass fiber-reinforced grades as well as in a variety of opaque and transparent colors.
The unmatched strength and durability of Radel® PPSU make it a superb specialty polymer for reusable instruments used by the surgeon, such as handles, knobs, trials and grips. Additionally, Radel® PPSU enables cases and trays to retain their toughness and withstand broad temperature ranges during repeat sterilization and disinfection.
Ixef® PARA (polyarylamide) is a high-performance specialty polymer that provides rigidity, dimensional stability and metal-like strength for plastic surgical instruments. The properties of this sophisticated polyamide combine tensile and flexural strength with an aesthetic, ultra-smooth finish. These advanced qualities allow Ixef® PARA to withstand high-energy gamma radiation without significant changes to its original physical appearance or properties. Additionally, Ixef® PARA can be sterilized in bulk, which helps to reduce costs and enables OEMs to produce affordable, single use surgical instruments. Solvay offers Ixef® PARA in a wide range of gamma-stabilized (GS) colors that facilitate the differentiation of surgical instrument sizes and present OEMs with unique branding opportunities. These GS resins are tested under ISO 10993:1 for biocompatibility and demonstrate no evidence of cytotoxicity, sensitization, intracutaneous reactivity or acute systemic toxicity.
Solvay’s Ixef® PARA supports a multitude of single use, polymer surgical instruments such as inserters, curettes, needle holders, forceps, retractors and extractors. Additionally, Ixef® PARA is ideal for single use spinal surgery kits that enhance operating room efficiency, eliminate reprocessing costs and play an essential role in reducing the root causes of surgical site infections.
AvaSpire® PAEK (polyaryletherketone) is a family of customized high-performance polyketones that fill cost and performance gaps between classes of other medical grade plastics. This enhanced thermoplastic offers superior chemical resistance and mechanical properties that can be reinforced by glass or carbon fiber. The improved ductility and toughness of AvaSpire® PAEK paired with its excellent aesthetics and colorability produces a variety of grades that outperform comparable PEEK (polyetheretherketone) polymers. AvaSpire® PAEK offers an unparalleled combination of stiffness, strength and chemical resistance at up to 30% lower cost than other PEEK materials used in reusable instruments.
AvaSpire® PAEK is used in a variety of applications such as cases, trays, knobs, handles and grips. The upgraded properties of AvaSpire® PAEK can be customized, tailored and reinforced with glass or carbon fiber to deliver cost-effective surgical instruments.
KetaSpire® PEEK (polyetheretherketone) incorporates Solvay’s enhanced polymer production technology to offer distinct performance advantages in a variety of grades. This specialty polymer displays the best combination of fatigue and chemical resistance and can operate at higher temperatures than comparable materials. Additionally, KetaSpire® PEEK provides single use plastic instruments with higher purity and improved toughness. This high-performance thermoplastic is available in neat grades, glass and carbon fiber reinforced grades, wear resistant SL grades and natural-colored powders. These outstanding properties enable KetaSpire® PEEK to replace metal in surgical instruments used in severe end-use environments. KetaSpire® PEEK is examined for gamma stability under USP Class VI testing for compatibility with the most relevant single use sterilization methods.
KetaSpire® PEEK is used in various surgical applications such as handles, knobs and grips. Glass fiber and carbon fiber reinforced KetaSpire® PEEK grades deliver excellent mechanical robustness required for more demanding, reusable structural applications.
Udel® PSU (polysulfone) is a high-performance thermoplastic that offers a superior combination of thermal stability, high strength and toughness. This rigid, semi-tough, transparent thermoplastic offers enhanced stiffness and excellent biocompatibility. Udel® PSU resins provide polymer instruments with higher heat resistance and better hydrolytic stability than polycarbonate, which makes them steam sterilizable. This high-performance specialty polymer meets the industry standard for gamma sterilization under USP Class VI Testing.
Udel® PSU excels in fluid handling applications such as membranes, heart valve sizers, retractors, final product bags and lids used for containment.