Smith & Nephew Inc. (NYSE:SNN) won 510(k) clearance from the Food & Drug Administration for new labeling on its Legion knee implant, which it says can now last up to 30 years.
The British medical product conglomerate’s Memphis-based orthopedics division ran tests simulating 30 years of physical activity on the implant, which uses SNN’s Verilast technology. Prior versions were labeled for a 10- to 15-year duration post-implantation.
Orthopedics division president Joseph DeVivo called the new FDA clearance "a generational leap forward" in prepared remarks, saying the company is aiming to develop implants that last for a patient’s entire lifetime.
The Verilast technology produced an 81 percent reduction in wear, which is the leading cause of knee replacement failure. When knee implants fail, patients typically require revision surgery to replace the original with a more invasive and expensive device, increasing the risk of infection and bone loss.