The new material enables the medical device manufacturer to maintain the same design features of the existing implants in the cervical intervertebral fusion devices which use the Victrex Peek-Optima HA Enhanced implantable polymer from Invibio Biomaterial Solutions.
The cages are intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one level from C2-T1. Talos-C (HA) Cervical Intervertebral Body Fusion (IBF) devices are for use with autologous bone graft to facilitate fusion. The interbody cage contributes to the fusion process, as it is strong, versatile and based on Peek-Optima polymer compounded with hydroxyapatite (HA), which is a well-known osteoconductive material for enhancing bone apposition, claims the company.
Research led to the addition of the enhanced polymer to the osteoconductive hydroxyapatite component. It is completely integrated throughout the polymer and consequently throughout the implant. Research and discussion with surgeons determined an implant that increases intimate bony contact with natural patient anatomy, and an interbody that enhances the healing process throughout the whole implant, was the best alternative. The polymer has a modulus of elasticity close to human bone plus HA, a material that enhances the grafting materials used by surgeons.
Peek-Optima HA Enhanced offers artifact-free imaging, allowing visual assessment of the fusion mass. A previous study that evaluated the bone on-growth of the two implantable polymers in a bone defect model in sheep, revealed that it resulted in approximately 75% direct bone apposition as early as four weeks following implantation.
In the European Union, two implants made from the PEEK-OPTIMA HA Enhanced implantable polymer have received the CE mark approval.