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Solvay Launches 30% CF-reinforced Radiolucent PEEK for Implantable Devices

Published on 2017-12-01. Author : SpecialChem

Zeniva® PEEK
Solvay has 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. 
  • This implies, 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

  • 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.

Radiolucent Polymer

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.

Reducing Manufacturing Costs

Jeff Hrivnak, business manager for Healthcare at Solvay’s Specialty Polymers global business unit, said:
“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. 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.”

ISO & cGMP-compliant Facility

  • 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

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Source: Solvay
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