Sternal closure bone cerclage wiring SternoEaZip®

monofilament polymer

PEEK-OPTIMA® polymer, provided by Invibio, is now recognized as a high performance biomaterial in worldwide. It is formulated to meet the most exacting in-vivo criteria and present excellent mechanical performance, plasticity, chemical resistance and biocompatibility. It is also capable to be repeatedly sterilized without impairing performance and behaves highly radiolucent CT/MRI imaging without scattering or artifacts. PEEK-OPTIMA polymer has been widely utilized in cardiovascular, dental, neurological and orthopaedic implants and globally accumulated more than 9 million implant cases Excellent Biocompatibility Good biological characteristics and histocompatibility Capable to sustain repeated steam, ETO sterilization and Gamma irradiation Non-cytotoxic, non-carcinogenic, non-conductive,hydrolysis resistance and corrosion resistance Tried and Tested Test material implanted in paravertebral muscle for one year caused virtually no response-mild fibrosis, or in some cases a light fibrous capsule. There was no muscle degeneration, nor necrosis, or any other significant change. PEEK-OPTIMA® Biocompatibility Tests • Genotoxicity ISO 10993-3 • Hemolysis (Extract) ISO 10993-4 • Cytotoxicity ISO 10993-5 • Biostability Local Effects of Implantation ISO 10993-6 • Sensitization ISO 10993-10 • Pyrogenicity ISO 10993-11 • Chemical Analysis ISO 10993-18 • USP Plastic Class VI Systemic Toxicity Study • USP Plastic Class VI Intracutaneous Toxicity Study PEEK-OPTIMA® is an inherently pure inert material. Extensive biocompatibility testing demonstrated no evidence of cytotoxicity, systemic toxicity, irritation or any macroscopic reaction response.