Sternal Fixation System
A totally non-metallic solution dedicated for reliable and rigid fixation of the sternum
PEEK-OPTIMA® polymer, provided by lnvibio, 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 Imaging Compatibility
PEEK is a high molecule polymer with better imaging compatibility.
- Non-magnetic and MRI safe
- Highly translucent to X-ray and CT compatible
- Artifact-free and scattering-free
CT value of PEEK sternal band: 50-l00H u
PEEK performs excellent histocompatiblity and biological characteristics. Capable to sustain repeated steam, ETD sterilization and Gamma irradiation. Non-cytotoxic, non-carcinogenic, non-conductive,hydrolysis resistance and corrosion resistance.
- Withstand 3,000 times of autoclave sterilization at 134°
- Corrosion resistance and fatigue resistance
- No deformity after gamma radiation
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 lntracutaneous 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.
Outstanding Bio-Mechnical Character
Exceeding tensile strength to native bone with better protection.
Comparable mechanical strength to native bone and capable to distract stresses effectively when deformity occurs.
Mechanical Strength Comparison Chart
Identify the appropriate location and pass PEEK band through intercostal space.
Remove PEEK band needle
Reduce sternal halves and secure the locking mechanism in the intercostal space to minimize implant profile
Tension PEEK band with application instrument
Remove subsequent implant with application instrument
Office: +27 (0)87 150 2806
Fax: +27 (0)86 260 1821