Alpharetta, Ga.-based plastics manufacturer Solvay Specialty Polymers USA LLC has expanded its range of Zeniva polyetheretherketone (PEEK) resins for use in implantable medical devices. Zeniva PEEK resins are part of a family of polymers marketed by Solvay known as Solviva Biomaterials, the only family of plastics produced by the company that are suitable for implantation in the body for more than 24 hours.
According to the company, the new PEEK-based material Zeniva ZA-520 provides image-contrasting capabilities for optimal visualization with X-ray, computed tomography (CT), and magnetic resonance imaging (MRI) imaging systems. ZA-520 contains an image-contrasting additive to make it radio-visible, and the 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.
The Zeniva PEEK range of products are marketed as offering advantages over metals like titanium and cobalt chrome for applications such as intervertebral devices. The PEEK based material offers 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.
Solviva Biomaterials thermoplastics are manufactured in compliance with ISO 13485 and under the relevant aspects of current good manufacturing practices. In addition, all Solvay’s materials are tested in an accredited lab that is ISO 17025 compliant.
Solvay Specialty Polymers is a global supplier of thermoplastics for both implantable and non-implantable medical devices.