Florence, KY and Kelsterbach, Germany– Ticona announces two new grades of GUR ultra-high molecular weight polyethylene (UHMW-PE) with vitamin E that are available for sampling and testing in orthopedic implants.
Vitamin E, a biocompatible antioxidant, provides additional oxidation stability to the engineering thermoplastic that should further extend the life of artificial prosthesis replacements.
“GUR UHMW-PE from Ticona has long been the ‘gold standard’ for orthopedic implants,” says Tom Scheetz, global director GUR.
“Now, with the addition of a homogeneous content of 1,000 parts per million of vitamin E (alpha-tocopherol) as a stabilizer amount, these new grades — GUR 1020-E and 1050-E — should allow sufficient irradiation behavior as well as effective oxidation resistance for improved implant wear.”
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The outstanding performance of GUR UHMW-PE for use in surgical orthopedic implants has been proven since the 1960s.
With an excellent combination of properties, including biocompatibility, high abrasion resistance, impact strength and fatigue and crack resistance, this engineering thermoplastic meets the standards of the United States Pharmacopeia (USP) Class VI, and complies with U.S. Food and Drug Administration (FDA) regulations.
In addition, GUR UHMW-PE meets the requirements of ASTM F648, the comparable ISO standard 5834-1/-2 for starting materials and semi-finished products and ASTM F2695: "Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications".
Today, more people are relying on synthetic orthopedic joints or joint components to replace hips, knees, shoulders, spine components, elbows or ankles, in addition to worn and damaged replacements, because they offer high functionality over a long lifetime.
These implants, which need to be sterilized, can become oxidized when subjected to modern irradiation techniques. Now GUR UHMW-PE with vitamin E should reduce susceptibility to oxidation in this process.
Every year, an estimated 1.5 million orthopedic joint replacement operations are performed worldwide. In view of the aging and increasingly overweight population, it is anticipated that the number of surgeries will continue to rise.
The new innovative GUR UHMW-PE grades containing vitamin E should provide further oxidative stability that is associated with improved implant wear, which may result in the avoidance of unnecessary follow-up surgeries.