Invibio Biomaterial Solutions, the leading solutions provider of PEEK-based biomaterials, manufacturing and application knowledge to medical device manufacturers worldwide, has today announced its launch of “PEEK-OPTIMA HA Enhanced Polymer”. The implantable biomaterial grade uniquely combines two clinically proven advanced biomaterials for enhanced bone apposition1: PEEK-OPTIMA, the principal PEEK-based biomaterial with over ten years of proven history in clinical use, and Hydroxyapatite (HA), a well-known osteoconductive material.
Hydroxyapatite (HA) is fully integrated into the PEEK-OPTIMA Natural grade to provide a complete homogeneous compound which ensures that HA will be present at all surfaces of a device. John Devine, Emerging Business Director explained, “Although PEEK is the most popular chosen material for interbody fusion applications, surgeon feedback has indicated that a version of PEEK that enhances bone ongrowth on all sides of the device could be more effective. Invibio has invested in this new grade that offers the same advantages of PEEK-OPTIMA™ and additionally a superior solution for bone apposition. With HA available across the whole device the opportunity for bone ongrowth is virtually unmatched with alternative bone apposition technologies” Devine concludes, “We believe the launch of PEEK-OPTIMA™ HA Enhanced provides surgeons with improved technologies and enables device companies to differentiate their product offerings. “
Within four weeks of implantation Invibio PEEK-OPTIMA HA Enhanced polymer demonstrated enhanced bone apposition compared to PEEK-OPTIMA™ Natural, in a pre-clinical in vivo study using a sheep model. Within 12 weeks of implantation the bone apposition levels are maintained with the new grade.
PEEK-OPTIMA HA Enhanced Biomaterial provides excellent mechanical properties and performance, proven biocompatibility, a modulus similar to cortical bone, reducing stress shielding and a high degree of radiolucency that allows for clear fusion assessment. Developed by the world leader in implantable PEEK-based biomaterials this innovation not only offers the same processing simplicity as PEEK-OPTIMA, but also omits the extra processing time and expense of alternative bone on-growth technologies, such as coatings.
Professor Bill Walsh Director of Surgical & Orthopaedic Research Laboratories, University of New South Wales will present the latest data on PEEK-OPTIMA™ HA Enhanced, the new material for bone apposition, at the upcoming spinal meetings Eurospine, 1-4 October 2013, Liverpool, UK and NASS, 9 – 11 October 2013, New Orleans USA. For more information visit: http://InvibioSpine.com. 1 Study evaluated the bone in-growth and on-growth of PEEK-OPTIMA Natural and PEEK-OPTIMA HA Enhanced in a bone defect model in a sheep. Data on file at Invibio. This has not been correlated with human clinical experience.