United Orthopedic Corporation receives FDA clearance for vitamin E-infused highly crosslinked polyethylene hip liner
United Orthopedic Corporation announced it received FDA clearance for its vitamin E-blended highly crosslinked polyethylene hip liner.
According to a company press release, the vitamin E highly crosslinked polyethylene hip liner, known as E-XPE, includes a combination of crosslinked polyethylene and vitamin E that is intended to optimize wear resistance without compromising oxidative stability and mechanical properties. Results from accelerated aging tests demonstrated E-XPE inserts and liners yielded 60% and 75% reduction, respectively, in gravimetric wear. The E-XPE material offers greater strength compared with re-melted highly crosslinked polyethylene and maintains oxidation resistance, according to the release.
“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,” Calvin Lin, president of United Orthopedic Corporation USA, said in the press release. “Clearance of our E-XPE, a vitamin E highly crosslinked 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.”