Solvay Advanced Polymers, LLC, announced today that 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, Calif.
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, 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 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 can 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.
KetaSpire PEEK is available in unfilled, glass-reinforced, and carbon-reinforced grades and can be easily processed via standard injection molding, extrusion, and compression molding processes.
AvaSpire modified PEEK is a line of proprietary PEEK-based formulations with unique advantages that bridge price and performance gaps. This offering of colored PEEKbased 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. They give medical OEMs unique branding opportunities and provide healthcare professionals with a quick visual reference for identifying instrument types and sizes.
Solvay also offers a family of Solviva™ Biomaterials for use in implantable medical devices that are in contact with bodily fluids or tissues for greater than 24 hours. The product line includes Zeniva™ PEEK, Proniva™ self-reinforced polyphenylene, Veriva™ polyphenylsulfone and Eviva™ polysulfone.
About Solvay Advanced Polymers
Solvay Advanced Polymers, LLC, produces more plastics with more performance than any other company in the world. This gives design engineers worldwide more ways to solve top design challenges in automotive, healthcare, electronics, aerospace and other demanding industries. Learn more at
www.solvayadvancedpolymers.com.
SOLVAY is an international industrial Group active in Chemistry. It offers a broad range of products and solutions that contribute to improving quality of life. The Group is headquartered in Brussels and employs about 19,000 people in 50 countries. In 2009, its consolidated sales amounted to EUR 8.5 billion. Solvay is listed on the NYSE Euronext stock exchange in Brussels (NYSE Euronext:
SOLB.BE - Bloomberg:
SOLB.BB - Reuters:
SOLBt.BR). Details are available at
www.solvay.com.
Press Contact:
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