Thornton Cleveleys (UK) – Invibio Knee Ltd, a subsidiary of Invibio Biomaterial Solutions has partnered with Maxx Orthopedics, Inc. to develop a PEEK-OPTIMA® femoral knee1 replacement. The technology is being developed to address some of the unmet needs of more than half a million patients2 annually who are not satisfied with their outcome after total knee arthroplasty using metal-based knee solutions. An international multi-centre pre-market clinical trial is currently in planning to evaluate the new technology.
For more than 15 years, Invibio Biomaterial Solutions has been pioneering PEEK-OPTIMA-based medical device solutions, and consequently supporting device companies around the world with innovations as well as manufacturing and in-depth knowledge to advance the medical device market. Spinal implants, to mention but one example, based on biocompatible PEEK-OPTIMA polymers are now widely recognized and are used frequently within the spinal fusion market. Today, Invibio solutions are being used in more than five million implanted devices worldwide.3 The company´s PEEK-OPTIMA biomaterials deliver performance characteristics such as modulus and flexural strength close to that of cortical bone, and radiolucency that allows artefact-free imaging both during and after implantation.
Maxx Orthopedics designs, develops and supplies joint replacements such as its flagship product, the Freedom Total Knee® System which has received 510(k) clearance by the United States Food & Drug Administration (US FDA). Launched in 2009, Maxx’s Freedom Knee recently completed over 25,000 successful implantations worldwide, receiving industry praise such as Frost & Sullivan's “Product Differentiation Excellence Award in Orthopedic Knee Joint Replacement”. The Freedom Knee offers transitional sizing options to support better surgeon choice for fit according to patient size and stature. It was designed also to support the deep knee bending and range of motion needs of today’s patients, and features an all-poly tibial component specifically designed for high flexion.
*) Invibio Knee Ltd. is a subsidiary of Invibio Biomaterial Solutions
1) PEEK-OPTIMA femoral knee product is in the pre-market phase.
2) R. B. Bourne et al. (2010), Patient satisfaction after total knee arthroplasty: who is satisfied and who is not?, Clinical Orthopaedics and Related Research, 2010, Vol. 468 (1), 57-63
3) Data on file at Invibio Biomaterial Solutions
Invibio® and PEEK-OPTIMA® are registered trademarks of Invibio Ltd.
Freedom Total Knee® is a registered trademark of Maxx Orthopedics.
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