Smith & Nephew orthopaedics division has received 510k clearance for claims related to Verilast technology’s ability to 'provide wear performance sufficient for 30 years of actual use under typical conditions.' The company has presented the results of testing on its Verilast technology for knee replacement implants.
After simulating 30 years of physical activity on the company’s Legion knee replacement, Smith & Nephew Verilast technology produced an 81% reduction in wear, the cause of knee replacement failure. The FDA has reviewed the results.
Smith & Nephew said that typically, if a knee replacement fails due to wear, the patient will undergo a ‘revision’ surgery in which the original components will be replaced with more invasive, more expensive ones. While there may be some decrease in implant performance, the primary costs of revision surgery are in its risk of infection and bone loss for the patient and the procedure’s cost for the healthcare system.
The company said that the Verilast technology may reduce the risk of failure for patients who would have been revised due to wear.
Joseph DeVivo, president of Smith & Nephew Orthopaedics, said: “Physically active patients want to end their knee pain for good. We’re working to make knee implants that last a lifetime that’s our goal, and we’ve validated Verilast technology out to 30 years for a market that views 10 to 15 years as the gold standard. This is not an incremental improvement; it’s a generational leap forward for active patients.”
Scott Elliott, senior vice president and general manager of global knee franchise at Smith & Nephew Orthopaedics, said: “Verilast technology is the unique combination of our exclusive Oxinium material and the most advanced XLPE on the market. Together, they yield virtually indiscernible wear. After performing wear simulator testing of the knee replacements over three continuous years, we have confirmed that this Smith & Nephew knee replacement made with Verilast technology, under normal circumstances, is expected to last for 30 years.”