Solvay Advanced Polymers, LLC, a part of Solvay Group recently announced that its KetaSpire PEEK (polyetheretherketone) and AvaSpire modified PEEK have achieved ISO 10993 biocompatibility compliance for use in limited-exposure medical devices and instruments. The company made the announcement at the MD&M West exposition (Booth No. 2894) in Anaheim, California. Based on rigorous biocompatibility testing, KetaSpire PEEK and AvaSpire modified PEEK resins demonstrate no evidence of cytotoxicity, sensitization, irritation or acute systemic toxicity as defined by ISO 10993:1. As a result, the company claims they can be considered for use in a wide variety of healthcare applications, including orthopedics, medical devices, surgical and dental instruments, and drug delivery systems.
KetaSpire PEEK, the company states, is one of the industry's most chemically resistant plastics and also offers excellent strength, superior fatigue resistance, and a heat deflection temperature up to 315°C (599°F). It is claimed to withstand more than 1,000 cycles of steam sterilization without any significant loss of properties and is also compatible with other sterilization methods, including ethylene oxide, vaporized hydrogen peroxide, and gamma radiation. In addition, AvaSpire modified PEEK is a line of proprietary PEEK-based formulations with unique advantages that bridge price and performance gaps. This offering of colored PEEK-based resins is a first for the healthcare industry, according to Kathleen Murtagh-Galea, healthcare market manager for Solvay Advanced Polymers. These resins are available in 10 vivid colors, including blue, green, yellow, purple, red, pink, and black which enables medical OEMs unique branding opportunities and provide healthcare professionals with a quick visual reference for identifying instrument types and sizes.