Solvay launches new radio visible grade of Zeniva PEEK for implantable medical devices

Solvay Specialty Polymers USA, LLC, has expanded its range of Zeniva polyetheretherketone (PEEK) resins for use in implantable medical devices. A new radio visible PEEK-based material, Zeniva  ZA-520, provides image contrasting capabilities for optimal visualization with x-ray, CT, and MRI imaging systems. The company made the announcement at the 2012 SpineWeek conference and exhibition May 28-June 1 in Amsterdam.

Zeniva PEEK is one of the four high-performance polymers that comprise the company’s family of Solviva Biomaterials available for use in implantable medical devices. New Zeniva ZA-520 compound, which contains an image contrast additive, offers medical device companies all the performance benefits of Zeniva PEEK along with enhanced radio visibility.

Zeniva ZA-520 compound provides visibility of an implant without the artifacts that are common with competitive metallic-based materials. The new compound is available in resin (for injection molding) and rod stock which can be high-precision machined for production of a full range of sizes and configurations.

Zeniva PEEK offers numerous advantages over metals like titanium and cobalt chrome for applications such as intervertebral devices. The material offers many important benefits including biocompatibility, chemical inertness, and a modulus of elasticity that is close to that of bone. Based on biocompatibility testing to ISO 10993 standards, Zeniva PEEK demonstrates no evidence of cytotoxicity, sensitization, irritation, or acute systemic toxicity.

Zeniva PEEK and the entire line of thermoplastic Solviva Biomaterials are manufactured in compliance with the relevant aspects of ISO 13485 and under the relevant aspects of current Good Manufacturing Practices. Solvay’s biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in an accredited lab that is ISO 17025 compliant.

In addition to Zeniva PEEK, Solvay’s Solviva Biomaterials line includes Proniva self-reinforced polyphenylene (SRP), one of the world’s stiffest and strongest unreinforced thermoplastics that offers exceptional hardness and biocompatibility; Veriva polyphenylsulfone (PPSU), which provides unsurpassed toughness combined with transparency and excellent biocompatibility; and Eviva polysulfone (PSU), which offers practical toughness in a strong, transparent polymer. These sterilizable products are available in injection molding and extrusion grades as well as rods and plates for machined components.