Radio-visible PEEK suits implantable medical devices
By Barry Copping
Posted 3 July 2012
Implants such as cervical spine fusion devices will benefit from image contrasting
Alpharetta, Georgia-based Solvay Specialty Polymers has expanded its range of polyetheretherketone (PEEK) resins for use in implantable medical devices. A new radio-visible compound grade, Zeniva ZA-520, provides image contrasting capabilities for visualisation with x-ray CT and MRI imaging systems.
Zeniva ZA-520 compound provides visibility of an implant without the artefacts common with competitive metal-based materials, according to Solvay. The new compound is available in resin form (for injection moulding) and rod stock which can be high-precision machined.
Advantages claimed for the material over metals (for instance titanium and cobalt chrome) in applications such as intervertebral devices include biocompatibility, chemical inertness, and a modulus of elasticity close to that of bone. On the basis of biocompatibility testing to ISO 10993 standards, Zeniva PEEK is claimed to demonstrate no evidence of cytotoxicity, sensitisation, irritation or acute systemic toxicity.
Zeniva is manufactured in compliance with the relevant clauses of ISO 13485 and under Good Manufacturing Practice standards, according to Solvay. All materials are tested in an accredited laboratory that is ISO 17025 compliant.
As well as Zeniva PEEK, Solvay’s Solviva biomaterials range includes Proniva self-reinforced polyphenylene (SRP), cited as “one of the world’s stiffest and strongest unreinforced thermoplastics that offers exceptional hardness and biocompatibility”; Veriva polyphenylsulfone (PPSU), for which excellent toughness combined with transparency and excellent biocompatibility are claimed; and Eviva polysulfone (PSU). These sterilisable products are available in injection moulding and extrusion grades as well as rods and plates for machining.
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