United Orthopedic Corp. said today that the FDA cleared its E-XPE polyethylene knee insert. The device was designed to reduce the risk of oxidation in patients with knee replacements.
The E-XPE insert is made of highly cross-linked polyethylene blended with 0.1% vitamin E. United Orthopedic claims the composition of the device resists wear without compromising oxidative stability or mechanical properties.
“Clearance of our E-XPE polyethylene knee insert represents an important milestone in our knee portfolio,” president Calvin Lin said in prepared remarks. “Oxidation continues to be a concern for surgeons. The E-XPE polyethylene is resistant to oxidation and performs extremely well with respect to abrasive wear resistance.”
A study published last month in The BMJ found that knee replacement surgeries for patients with osteoarthritis yield minimal improvements in quality of life and are economically unattractive.
In the 7,405 patient-study, researchers evaluated the impact of total knee replacement procedures on quality of life for patients with knee osteoarthritis. The team also aimed to examine the differences in lifetime costs and quality adjusted life years as related to symptoms.
Results from the study showed that the procedure’s effectiveness would rise if it was offered only to patients with severe symptoms of osteoarthritis. Such a shift would improve the economic attractiveness of the procedure, the team added.