Maxx Orthopedics, Inc. (Philadelphia, Pennsylvania) and Invibio Biomaterial Solutions (W. Conshohocken, Pennsylvania) have begun a study and are reporting on the first patients to be implanted with the new, all polymer, PEEK-OPTIMA femoral knee component for primary total knee arthroplasty (TKA). The PEEK-OPTIMA femoral component is based on Maxx Orthopedics’ Freedom Total Knee System featuring high-flexion, bone-conserving design.
This metal-free solution “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.”
Ian Revie, Business Development Director, Trauma & Orthopaedics, Invibio, told OTW, “Invibio is well known in the industry for its high-performance polymer solutions. We have become market leaders not only through product excellence in PEEK solutions, but also by collaborating with companies that can help us to create new supply chains and accelerate growth for our customers—all with laser focus on delivering innovative solutions that address clinical challenges for the medical device industry.”
“Maxx Orthopedics, an innovative, forward thinking team with a focus on patient first, is perfectly placed to do this, with their proven Freedom Knee design and market footprint in orthopaedic devices. Together, we are material scientists, engineers, product designers and innovators.”
The Medical Business Director of Invibio Dr. John Devine explained the historic importance of these new components for TKA to OTW, “For decades, patients needing a TKA have been faced with metal implants, and the poor levels of patient satisfaction with current TKA such as problems with pain, discomfort, allergies or costly revisions are well documented.”
“We are excited about the potential of improving patient outcomes and strongly believe this all-polymer knee implant could transform the patient experience by providing a more natural feeling solution, and a chance to improve mobility for millions of patients worldwide. We have seen PEEK transform the spinal implant market, and in the near future we believe it could transform the knee implant market. This is certainly an exciting milestone reached after years of research and development investment however, we have to be cautious and wait for the full results of the trial.”
Maxx Orthopedics CEO Ashesh Shah told OTW, “Effective innovation requires both creative thinking and methodical execution. To adapt our Freedom Total Knee femoral component to PEEK’s unique manufacturing requirements, we needed a partner with deep knowledge of the polymer and a systematic approach to research and development. Invibio has over 20 years of proven clinical history to support their PEEK-OPTIMA polymers, which are used in approximately 13 million implanted devices worldwide, so they were the natural partner for this project. We have been working with Invibio for more than seven years, conducting extensive research, design development and pre-clinical evaluation of the product, and we complement each other perfectly.”
“With Invibio’s and Maxx Orthopaedics approach to innovation and business, we have developed a strong technology platform that opens the door to new potential solutions for patients that can be made available to the broader industry. Developing design and validation solutions, delivered from smart manufacturing processes, together we will address clinical performance requirements and meet regulatory standards for new technology”
Metal-Free Solution a “Door Opener”
Shah explained to OTW, “Consistent with our company mission, PEEK-OPTIMA polymer has the potential to improve patient satisfaction and quality of life, without increasing cost. By pairing the PEEK-OPTIMA femoral component with an all-polyethylene tibial component and taking advantage of increased manufacturing efficiency as compared to metal implants, we hope to provide a high-performance, high-value product that meets the needs of the global healthcare community. We believe that in the long term a metal-free solution to knee arthroplasty will not only improve patient satisfaction but will open the doors to a host of other innovations such as onsite 3D printing, economically affordable custom implants and dramatic reductions in inventory requirements.”
Asked about patient outcome information, Corey Perine, Maxx Orthopedics chief operating officer, commented to OTW, “While we cannot speak to details regarding patient outcomes at the present time, we can say that we are broadly encouraged by the results to date.”
Regarding the benefits to patients vs. metal implants, he noted, “In addition to the immediate benefits of less weight and the elimination of any metal ion release or metal sensitivity reactions, because PEEK-OPTIMA polymers is radiolucent, we may have better visibility of early aseptic loosening and mal-alignment in the operated joint. Furthermore, the mechanical properties of PEEK-OPTIMA polymers are closer to cortical bone than traditional metals, and some of our pre-clinical research suggests that may minimize stress shielding and bone resorption. Once we establish product safety, we intend to study the product further to establish these benefits concretely.”
