Meditech Spine, Atlanta, USA has received the US Food and Drug Administration (FDA) 510(k) clearance to market the next generation of its Talos line of interbody devices. These cervical intervertebral fusion devices rely on the novel implantable polymer from Invibio Biomaterial Solutions, Peek-Optima HA Enhanced. The new material solution enables the medical device manufacturer to maintain the same design features of the existing implants.
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 intended to be used with autologous bone graft to facilitate fusion. Peek-Optima HA Enhanced as the material for these interbody cages contributes to the fusion process, as it is strong, versatile and based on Peek-Optima polymer compounded with hydroxyapatite (HA), a well-known osteoconductive material for enhancing bone apposition.
"Our goal is to partner with industry leaders across all spectrums and we are excited to be a part of this pioneering material and process,” Bob Wolownik from Meditech Spine noted. The company extensively looked at the Peek-Optima data and discussed its characteristics with many surgeons. Research helped steer the decision at Meditech Spine to add theenhanced polymer to the product portfolio. “The osteoconductive hydroxyapatite component is more than just a surface coating or texture. It is completely integrated throughout the polymer and consequently throughout the implant. From our research and discussion with surgeons, we 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. We feel this gives our surgeons and their patients the best of both worlds."
