NORRISTOWN, PA — Maxx Orthopedics, Inc., and Invibio Biomaterial Solutions together announced the successful study initiation and first patients to be implanted with the new, all polymer, PEEK-OPTIMA™ femoral knee component for primary total knee arthroplasty (TKA). This pre-market, global feasibility study is designed to assess the safety and efficacy of the PEEK-OPTIMA™ femoral knee component in patient candidates receiving primary TKA.
The PEEK-OPTIMA™ femoral knee component combined with the Freedom® high-flex all-polyethylene tibial component provides a modern, metal-free alternative to the standard TKA. It offers surgeons and patients a femoral component that has the potential to correct component to bone material mismatch for preservation of femoral bone density, while avoiding patient complaints of metal sensitivity and achieving increased post-operative patient outcomes. Dr. John Devine, Medical Business Director of Invibio, stated “This is an exciting landmark moment, and we will now adopt a cautiously optimistic approach and await the full results of the clinical study. The potential for superior clinical outcomes and improved patient satisfaction from a metal-free implant, together with improved health economic outcomes makes this a significant advancement in orthopedic technology.”
PEEK-OPTIMA™ polymers deliver performance characteristics such as modulus and flexural strength close to that of cortical bone, contributing to bone density preservation, and radiolucent material properties that allows artifact-free imaging both during and after implantation. The polymer has proven biocompatibility and biomechanical benefits in implantable spine, trauma and other devices that provides safety, longevity and reassurance to patients and surgeons.
The PEEK-OPTIMA™ femoral component is based on Maxx Orthopedics’ Freedom® Total Knee System high-flexion, bone-conserving design. “We are and have always been focused on delivering high value. We asked how we could significantly improve patient satisfaction and PEEK is potentially that solution. We are using a time-tested material in a new way to hopefully improve bone quality and overall longevity”, said Ashesh Shah, CEO of Maxx Orthopedics.
Maxx Orthopedics and Invibio™ Biomaterial Solutions will be displaying PEEK-OPTIMA™ femoral component at the AAOS Annual Meeting, September 1-3, in San Diego, CA (Booth #3117).
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