Implantable Polymers

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.

• Product Flyer
• Product Data Sheet Chirulen^® 1020
• Product Data Sheet Chirulen^® 1020 + Vitamin E
• Product Data Sheet Chirulen^® 1020 Cross-linked
• Product Data Sheet Chirulen^® 1010 Cross-linked + Vitamin E 
• Product Handling Information Sheet

 
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.

• Product Flyer
• Product Data Sheet Chirulen^® 1050
• Product Data Sheet Chirulen^® 1050 + Vitamin E
• Product Handling Information Sheet

 Extrulen^TM 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.

• Product Flyer
• Product Data Sheet Extrulen^TM 1020
• Product Data Sheet Extrulen^TM 1020 + Vitamin E
• Product Handling Information Sheet

 

Extrulen^TM 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.

• Product Flyer
• Product Data Sheet Extrulen^TM 1050
• Product Data Sheet Extrulen^TM 1050 + Vitamin E
• Product Handling Information Sheet

Cross-linking

Chirulen^® and Extrulen^TM 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 Extrulen^TM 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.

• Product Data Sheet
• Product Handling Information Sheet
• Delivery Programme