FDA Clears Vitamin E Highly Cross-Linked Polyethylene Hip Liner

United Orthopedic Corporation (UOC) tells us that the U.S. FDA has cleared its vitamin E highly cross-linked polyethylene (E-XPE™) hip liner, representing a new generation of highly cross-linked polyethylene blended with vitamin E to enhance wear resistance without compromising oxidative stability and mechanical properties.

Background

An estimated 4.7 million Americans have undergone total knee arthroplasty (“TKA”) and 2.5 million have undergone total hip arthroplasty (“THA”). The prevalence of THA rises to nearly 6 percent by 80 years of age. The prevalence of TKA rises to nearly 10 percent by 80 years of age.

UOC describes itself as a leading international designer, manufacturer, and distributor of innovative orthopedic implants and instruments. By incorporating Vitamin E into its hip liner the theory goes that wear resistance is increased as a result of reduced oxidative degradation of polyethylene chains, analogous to its antioxidant effect in reducing degradation of cell membrane phospholipids. Vitamin E -stabilized UHMWPE is a biocompatible material with good mechanical, wear, and oxidative proprieties. Results from accelerated aging tests show that E-XPE inserts and liners exhibited a 60 percent and 75 percent reduction, respectively, in gravimetric wear.  E-XPE material provides greater strength in comparison to re-melted highly crosslinked polyethylene while maintaining oxidation resistance as demonstrated in mechanical tests.

Company comments

“Oxidation continues to be a concern for surgeons. Over time, wear of conventional polyethylene can generate debris in the joint, triggering local inflammation that results in bone loss which is one of the biggest causes of late-term failure in hip and knee replacements,” said Calvin Lin, President of United Orthopedic Corporation USA. “Clearance of our E-XPE™, a vitamin E highly cross-linked polyethylene, provides surgeons with an alternative implant for their patient. Our vertically integrated manufacturing process affords us the flexibility to design, manufacture and distribute implants or instruments that address many of the most significant needs in the orthopedic industry.”

Source: PR Newswire

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