Victrexplc: Victrex plc Announces in Partnership with Maxx Orthopedics Inc, FDA Grants IDE Approval for Freedom Total Knee System with Invibio PEEK-OPTIMA Femoral Component as Staged Study

Victrex plc announced that, in partnership with Maxx Orthopedics Inc, the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for Freedom Total Knee System with Invibio PEEK-OPTIMA Femoral Component, as a staged study. The study, projected to be 120 patients at clinical sites in the US, will compare using the PEEK-OPTIMA Femoral Knee Component to a controlled registry of the same system using traditional metal femoral components. The US study will build on the existing clinical trial for PEEK Knee at sites in Belgium, India and Italy, which has been progressing strongly since the first implant in 2021, with no clinical intervention. A regulatory submission in India is also expected imminently, supporting the potential for a commercial PEEK Knee in the market in 2025.