New high-performance biocompatible polymer to be available in China for spinal fusion implant

16-Nov-15

An innovative high-performance polymer for spinal fusion implants, PEEK-OPTIMA® HA Enhanced, which enables early and direct bone apposition, has now passed biocompatibility testing in China. This paves the way for approval by the China Food and Drug Administration (CFDA) and local legal compliance, as confirmed in the Regulatory Affairs (RA) clearance process. In Europe and the USA, medical device manufacturers are already offering a new generation of implants based on this superior material. PEEK-OPTIMA HA Enhanced is available from Invibio Biomaterial Solutions ("Invibio"), a Victrex Plc company, the world leading provider of proven PEEK-based biomaterial solutions. This Enhanced polymer is an implantable material that uniquely combines two clinically-proven advanced biomaterials for enhanced bone apposition: PEEK-OPTIMA, the principal PEEK-based biomaterial from Invibio that has over 15 years of proven history in clinical use, and hydroxyapatite (HA), a well-known and proven osteoconductive material. Biocompatibility testing of PEEK-OPTIMA HA Enhanced has been successfully completed, in China, at CFDA Tianjin Medical Device Supervision and Testing Center. The associated results are available in reports released on Delayed Type Hypersensitivity, Skin Irritation, Genotoxicity, Systematic toxicity, In-vitro cytotoxicity, Sub-chronic toxicity and 26 week bone implantation. Successful passing of the '26 week bone implantation test', which assesses the bone implantation process at 26 weeks, is particularly significant because it will reduce the time involved in the application process, when medical device manufacturers seek CFDA approval. Benefits of PEEK-OPTIMA HA Enhanced include a modulus similar to that of bone, radiolucency and artifact-free imaging, whether by X-ray, MRI or CT scanning, allowing visual assessment of the fusion mass, biocompatibility and long-term stability. Hydroxyapatite (HA), a natural constituent of human bone, enhances bone apposition on all the surfaces of a spinal implant and eliminates the time and expense of applying coatings. A study that evaluated the bone on-growth of the two implantable polymers in a bone defect model in a sheep, revealed that PEEK-OPTIMA HA Enhanced increased interfacial shear strength with bone more than four-fold at four weeks following implantation and resulted in over 75% direct bone apposition.