Loader
Home »   ...  » Products » MediTECH® Implantable Polymers » Longterm Implantation

Longterm Implantation

Premium Implantable Polymer Products

Implant products made from Mitsubishi Chemical Advanced Materials' semi-finished materials help millions of patients around the world to maintain or restore a high quality of life. For more than 30 years, the MediTECH® Division of Mitsubishi Chemical Advanced Materials has been supplying leading manufacturers of orthopedic implants worldwide.

Mitsubishi Chemical Advanced Materials offers a product range that includes both high quality PEEK [polyetheretherketone] and UHMW-PE [ultra-high molecular weight polyethylene] products:

  • Zeniva® PEEK
  • Chirulen® / Extrulen® UHMW-PE

Zeniva® PEEK
ASTM F2026 Conformity

The MediTECH® Division at Mitsubishi Chemical Advanced Materials exclusively processes raw materials from Solvay SA for Zeniva® PEEK. These are fully conform with ASTM F2026 guidelines.

Chirulen® / Extrulen® UHMW-PE
ASTM F648, ISO 5834-1 / ISO 5834-2 Conformity

For our Chirulen® / Extrulen® UHMW-PE products, we use the GUR® premium resins from Celanese, which are designed for certain surgical orthopedic implant applications. These high purity resins meet the standards of ASTM F648, ISO 5834-1 and ISO 5834-2.

 

Global Manufacturing Sites

NORTH AMERICA


Production Site & Sales

Fort Wayne, Indiana, USA
Phone: +1 260 479 4100
meditech@mcam.com 

SOUTH AMERICA


Sales

Atibaia, São Paulo, Brazil
Phone: +55 11 2218 6200
meditech@mcam.com

EMEA (Europe, Middle East, Africa)

Production Site & Sales

Vreden, Germany
Phone +49 2564 301 116
meditech@mcam.com

ASIA PACIFIC


Sales

Shanghai, China
Phone +86 1370 1286 124
meditech@mcam.com

 

Global Product Offering

Zeniva® PEEK

Zeniva® PEEK is a high-performance, biocompatible polymer used primarily for orthopedic, cardiac and neurological implantable devices. It has a modulus very close to that of cortical bone plus excellent fatigue resistance and toughness. In addition, it offers numerous advantages over metals, such as a reduction of stress shielding, no heavy metal allergy or ion erosion, and has
radiolucent properties which allow x-ray
and CT scanning procedures without interference.

 

 

Long-term Implantation | Key Application Segment: Spinal Fusion Cages

Zeniva® PEEK is offered for use in implantable medical devices that are meant for long-term implantation.  

Performance benefits of Zeniva® PEEK shapes include:

  • Biostability
  • High strength and stiffness
  • Excellent fatigue resistance
  • Exceptional dimensional stability 
  • Radiolucency allows for X-ray and CT scanning

These shapes are ideal for the close tolerance machining of finished components, and for prototypes used in injection molding applications. 

Zeniva® PEEK resin and stock shapes comply with ISO 13485 manufacturing standards and meet current Good Manufacturing Practices (GMP). Based on rigorous biocompatibility testing, these products demonstrate no evidence of cytotoxicity, sensitization, irritation, or acute systemic toxicity as defined by ISO 10993. These products can be sterilized using all conventional methods, including gamma radiation, ethylene oxide, and steam.

Zeniva® PEEK ZA-500 - ASTM F2026 Conformity

Mitsubishi Chemical Advanced Materials' Zeniva® PEEK ZA-500 is a high viscosity material, characterized by a series of benefits: 

  • Full conformity with ASTM F2026
  • Highly resistant to changes in mechanical, thermal, and chemical properties after being exposed to gamma, steam, and ethylene oxide (ETO) sterilization 
  • Thermally accelerated aging studies spanning five years show that Zeniva® ZA-500 possesses a shelf-life in excess of 100 years at 23 °C

Stock Shapes

Zeniva® PEEK ZA-500 is available as stock shapes in the form of Rods and Plates: 

  • Rods diameter 6 - 80 mm
  • Plates thicknesses 15 and 40 mm
Product Data Safety Data 
Product Data Sheet Zeniva® PEEK ZA-500Safety Data Sheet Zeniva® PEEK ZA-500
Zeniva® PEEK Product Specification 

 

Zeniva® PEEK is a registered trade mark of Solvay SA.

Chirulen® 1020

Chirulen® 1020 is a compression moulded medical grade UHMW-PE made from GUR® 1020 raw material. It is used for artificial joint replacements in the form of shoulder, spine, elbow, hip, knee and ankle implants.
The product is available in sheets, rods, cut-to-size formats or customized preforms.

 
Chirulen® 1050

Chirulen® 1050 is a compression moulded medical grade UHMW-PE made from GUR® 1050 raw material. It is used for artificial joint replacements in the form of shoulder, spine, elbow, hip, knee and ankle implants.
The product is available in sheets, rods, cut-to-size formats or customized preforms.

Extrulen® 1020

Extrulen® 1020 is Mitsubishi Chemical Advanced Materials' extruded medical grade UHMW-PE made from GUR® 1020 raw material. It is used for in artificial joint replacement in the form of  shoulder, spine, elbow, hip, knee and ankle implants. The material is available in rods.

 

Extrulen® 1050

Extrulen® 1050 is Mitsubishi Chemical Advanced Materials' extruded medical grade UHMW-PE made from GUR® 1050 raw material. It is used for in artificial joint replacement in the form of  shoulder, spine, elbow, hip, knee and ankle implants. The material is available in rods.

Cross-linking

Chirulen® and Extrulen® are the market leading products for use in today's highly cross-linked Polyethylenes (XL-PEs). Clinical results and studies demonstrate significant improvements achieved in wear reduction and further improvements are in constant development.

Mitsubishi Chemical Advanced Materials 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 provides Chirulen® and Extrulen® 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 show mechanical properties to remain practically unchanged.

 

Life Science Grades

This group of biocompatible Life Science Grade materials has been specifically developed for applications in the medical, pharmaceutical and biotechnology industries.

  • Biocompatible materials
  • ISO 10993 compliance
  • Body contact duration less than 24 hours (up to 30 days for Ketron® CLASSIX LSG PEEK)

 

Learn more

Contact