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Mitsubishi Chemical Advanced Materials »   ...  » Products » MediTECH® / Life Science Grade » Implantable Polymers

Implantable Polymers

Products with proven success

For more than 30 years, Mitsubishi Chemical Advanced Materials' MediTECH® Division has supplied leading orthopaedic implant manufacturers with premium grade UHMW-PE under the Chirulen® and ExtrulenTMbrand names. Due to their superior physical and mechanical properties, cleanliness and consistency, Chirulen and Extrulen have become the materials of choice for articulating surfaces,
helping restore a higher quality of life to millions of patients worldwide.

MediTECH® uses GUR® Premium resins from Celanese, specified for use in
surgical orthopaedic implant applications. This highly pure resin complies
with standards 

ASTM F648
ISO 5834-1 and
ISO 5834-2

and exhibits excellent biocompatibility with skin, blood and tissue. We have instituted a series of tests and implemented quality control measures to produce materials that far exceed ASTM F648 and ISO 5834 requirements.

Chirulen® Extrulen™ XL (Crosslinking) Antioxidants Applications Ketron® CLASSIX™ LSG PEEK

Chirulen® 1020
A compression moulded medical grade UHMW-PE made from GUR® 1020 raw material. It is used for implants like hip, knee, elbow and shoulder.
The product is available in sheets, rods, cut-to-sizes or customized preforms.

 
Chirulen® 1050
A compression moulded medical grade UHMW-PE made from GUR® 1050 raw material. It is used for implants like hip, knee, elbow and shoulder.
The product is available in sheets, rods, cut-to-sizes or customized preforms.

 ExtrulenTM 1020
This is an extruded medical grade UHMW-PE made from GUR® 1020 raw material. It is used for implants, like hip, knee, elbow and shoulder and is available in  rods.

 

ExtrulenTM 1050
An extruded medical grade UHMW-PE made from GUR® 1050 raw material. It is used for implants, like hip, knee, elbow and shoulder and is available in rods.

Cross-linking

Chirulen® and ExtrulenTM are the market leading products for use in today's highly cross-linked Polyethylenes (XL-PEs) - with more than 10 years of clinical history and follow-up. Recent clinical results and studies demonstrate significant improvements achieved in wear reduction and further improvements are in constant development. Mitsubishi Chemical Advanced Materials EPP dedicates a considerable portion of their R&D efforts and know-how to the development of customized XL-PEs, also in combination with Vitamin E and other antioxidants.

E-Beam Irradiation                                      Gamma Irradiation

              

1 = penetration depth of electrons            5 = Co-60 Irradiation source
2 = primary electrons (source)                  6 = ϒ-quanta
3 = secondary electrons
4 = irradiated material

Antioxidants

Our products are completed by antioxidant additives like Vitamin E, HALS, customer antioxidants and others.
 
Example: Vitamin E
Sterilization and cross-linking by irradiation bear the risk of free radicals formed in the UHMW-PE which can result in in vivo oxidation and material degradation. 
Vitamin E known as an antioxidant has positive influence on this process and is used as a stabilizer for orthopaedic implants made from UHMW-PE.
Mitsubishi Chemical Advanced Materials EPP provides Chirulen® and ExtrulenTM shapes with Vitamin E as per customers' requirements. Tests have proven unaffected biocompatibilty of medical grade UHMW-PE blended with Vitamin E as well as shown mechanical properties to remain practically unchanged.

Mitsubishi Chemical Advanced Materials MediTECH® implant products have long-term record in orthopaedic joint replacement.

Examples are:

  • Hip
  • Knee
  • Elbow
  • Shoulder
  • Spine

Ketron® CLASSIX™ LSG PEEK stock shapes are produced from Invibio® PEEK-CLASSIX White resin. This material has a maximum body contact duration of 30 days and exhibits a unique combination of mechanical properties, temperature and chemical resistance. The composition of the Invibio PEEK-CLASSIX White resin complies with the regulations that apply in the Member States of the European Union (Directive 2002/72/EC, as amended) and in the United States of America (FDA) for plastic materials and articles intended to come into contact with foodstuffs.

Ketron CLASSIX™ LSG PEEK stock shapes have also been successfully type tested for their compliance with both United States Pharmacopeia (USP) and ISO 10993-1 guideline requirements for Biocompatibility Testing of Materials, and they come with full traceability from resin to stock shape. These features, added to an excellent sterilizability by means of steam, dry heat, ethylene oxide, plasma and gamma irradiation, make Ketron CLASSIX™ LSG PEEK stock shapes very suitable for applications in the medical, pharmaceutical and biotechnology markets.

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