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kontour Cranial Reparing System - PEEK (PSI)

kontour Cranial Reparing System - PEEK (PSI)

kontour Cranial Reparing System - PEEK (PSI)

Product catalog summary
Introduction to PEEK-OPTIMA Polymer
PEEK-OPTIMA polymer, developed by Invibio, is a high-performance biomaterial recognized globally for its excellent mechanical properties, plasticity, chemical resistance, and biocompatibility. It is widely used in cardiovascular, dental, neurological, and orthopedic implants, with over 5 million cases worldwide. The polymer is notable for its ability to be repeatedly sterilized without performance degradation and its high radiolucency in CT/MRI imaging.
Applications and Manufacturing
Kontour Medical leverages advanced CAD/CAM and 3D printing technologies to design and manufacture leading cranial implants using PEEK-OPTIMA. Their innovative approach has been recognized with a National Technology Award.
Product Specifications
The document lists various product codes for cranial implants, indicating a range of angles and dimensions to suit different medical needs. These implants are designed to match the natural contour of the brain and provide comfort and protection.
Material Properties
PEEK-OPTIMA is non-cytotoxic, corrosion-resistant, non-carcinogenic, non-conductive, and resistant to hydrolysis. It can withstand repeated sterilization processes and offers mechanical strength comparable to artificial bone, effectively distributing stress during deformation.
Biocompatibility and Testing
Extensive biocompatibility testing has shown no evidence of cytotoxicity, systemic toxicity, irritation, or significant macroscopic reactions. The material meets various ISO standards for genotoxicity, hemolysis, cytotoxicity, biostability, sensitization, pyrogenicity, and chemical analysis.
Mechanical and Thermal Properties
PEEK-OPTIMA exhibits superior tensile strength compared to native bone and provides better protection to the cerebrum. It is lighter and offers better thermal insulation, enhancing comfort for patients with bulky implants.
Conclusion
PEEK-OPTIMA polymer is a proven biomaterial offering excellent biocompatibility, mechanical strength, and imaging compatibility, making it a preferred choice for various medical implants.
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Catalog excerpts

kontour Cranial Reparing System - PEEK (PSI)-1

Excellent Biocompatibility Non-cytotoxic, corrosion resistance non-carcinogenic, non-conductive and hydrolysis resistance Good biological characteristics and histocompatibility Capable to sustain repeated steam, ETO sterilization and Gamma irradiation Outstanding Bio-Mechnical Character Exceeding tensile strength to the native bone and provide better protection to the cerebrum Comparable mechanical strength to the artificial bone and capable to distract the stress effectively when deformity occurs Better Imaging Compatibility Non-magnetic and highly translucent to X-ray CT/MRI imaging without scattering or artifacts Better comfort after implanting Lighter weight and more comfort for bulky implant Good thermal insulation to eliminate malaise due to the different temperature Perfect Contour Reconstruction Precisely match the natural contour and convenient to implant Literature proves clinical complications rate of PEEK implant comparable to the Titanium implant High Performance Biomaterial World Leading Manufacturing Technology CAD/CAM technology allows to restore the defect models and reconstruct the natural contour of the brain Product Code Kontour innovative technology in designing and manufacturing Patient-Specific Implant was rewarded the Second Class of National Technology Award. Cert No. 2014-F-30801-2-04-R06 Block 12, No.6, Qinling Avenue, Caotang Technology Industry Base, Xi'an High-tech Zone, Xi'an, China, 710304 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 5 million implant cases 1. Resource data is quoted from FDA database In conjunction with the outstanding PEEK-OPTIMA polymer performance, Kontour Medical utilizes advanced CAD/CAM and 3D printing technologies to design and manufacture the world leading cranial implants 2. RECONSTRUCT NATURAL CONTOUR

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kontour Cranial Reparing System - PEEK (PSI)-2

Better Imaging Compatibility Excellent Biocompatibility Non-cytotoxic, corrosion resistance non-carcinogenic, non-conductive and hydrolysis resistance Non-magnetic and highly translucent to X-ray CT/MRI imaging without scattering or artifacts Good biological characteristics and histocompatibility Capable to sustain repeated steam, ETO sterilization and Gamma irradiation 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. Fibroblasts...

 Open the catalog to page 2
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