Solvay unveils Zeniva® ZA-600 CF30 PEEK, a high-strength, injection moldable polymer for implantable devices
Alpharetta, Ga., Nov. 29, 2017--- Solvay, a leading global supplier of specialty polymers, announced new Zeniva® ZA-600 CF30 polyetheretherketone (PEEK), a 30 percent carbon fiber-reinforced, radiolucent polymer offered for implantable device applications. The latest addition to Solvay’s growing portfolio of Healthcare solutions, Zeniva® ZA-600 CF30 PEEK offers modulus very similar to cortical bone. That means, unlike implantable metals, it can help implants minimize reduction in bone density by maintaining normal stress on surrounding bone tissue.
Zeniva® ZA-600 CF30 PEEK offers strength twice that of unmodified PEEK, making it an excellent candidate for structural, load-bearing, implantable devices used in spine, hip and knee replacements. This quality allows designers to reduce the size and scale of their implanted devices to make them less intrusive. Like unmodified PEEK, Zeniva® ZA-600 CF30 polymer also offers exceptional creep resistance and the ability to withstand prolonged fatigue strain.
Solvay’s new specialty polymer also shares unmodified PEEK’s inherent radiolucency, giving it an advantage over metallic solutions that prohibit visualization of implants and fusions using x-ray, CT scan, MRI and other medical imaging methods.
“Zeniva® ZA-600 PEEK CF30 offers the orthopedic industry an innovative new structural material with the potential to dramatically reduce the manufacturing costs of implantable devices used for sports medicine, trauma and joint reconstruction,”said Jeff Hrivnak, business manager for Healthcare at Solvay’s Specialty Polymers global business unit. “Optimized for injection molding, this material opens the door to cost-effective, large-scale production of implants, offering OEMs the economic advantage they need to compete and succeed in this fast-growing market.”
Zeniva® ZA-600 CF30 PEEK is manufactured in a dedicated ISO 13485- and cGMP-compliant facility in the U.S. and is tested in ISO 17025 labs. It is part of Solvay’s Solviva® family of biomaterials, which offer a broad and growing range of options for implantable devices used in orthopedics, cardiovascular, spine and other applications. As with all Solviva® Biomaterials, production of Zeniva® PEEK polymer is carefully validated and enhanced controls provide product traceability. Detailed FDA Master Access Files (MAF) are available for the new material, along with additional regulatory support to help streamline customers’ time-to-market.
In addition to Zeniva® PEEK, Solvay’s Solviva® portfolio includes Veriva® polyphenylsulfone and Eviva® polysulfone. All Solviva® Biomaterials can be sterilized using conventional methods, such as gamma radiation, ethylene oxide and steam. They demonstrate no evidence of cytotoxicity, sensitization, intracutaneous reactivity or acute systemic toxicity, based on biocompatibility testing as defined by ISO 10993:1. These sterilizable products are available in grades for injection molding or extrusion, as well as stock shapes for machined components.
® Zeniva, Solviva, Veriva and Eviva are registered trademark of Solvay
Solvay Specialty Polymers manufactures over 1500 products across 35 brands of high-performance polymers – fluoropolymers, fluoroelastomers, fluorinated fluids, semi-aromatic polyamides, sulfone polymers, aromatic ultra-high performance polymers, and high barrier polymers – for use in Aerospace, Alternative Energy, Automotive, Healthcare, Membranes, Oil and Gas, Packaging, Plumbing, Semiconductors, Wire & Cable, and other industries. Learn more at www.solvayspecialtypolymers.com.
Solvay is a multi-specialty chemical company, committed to developing chemistry that addresses key societal challenges. Solvay innovates and partners with customers in diverse global end markets. Its products and solutions are used in planes, cars, smart and medical devices, batteries, in mineral and oil extraction, among many other applications promoting sustainability. Its lightweighting materials enhance cleaner mobility, its formulations optimize the use of resources and its performance chemicals improve air and water quality. Solvay is headquartered in Brussels with around 27,000 employees in 58 countries. Net sales were € 10.9 billion in 2016, with 90% from activities where Solvay ranks among the world’s top 3 leaders. Solvay SA (SOLB.BE) is listed on Euronext Brussels and Paris (Bloomberg: SOLB.BB - Reuters: SOLB.BR) and in the United States its shares (SOLVY) are traded through a level-1 ADR program.