PEEK into custom skull implants
H aving supplied its PEEK polymer to over 3 million implanted devices over the last ten years, US-based Invibio Biomaterial Solutions has another feather in its cap with Kelyniam Global using it for its Custom Skull Implants (CSI),
Kelyniam, an emerging medical device manufacturer, that recently received its FDA 510(k) clearance to market cranial implants will use Invibio's patented PEEK-OPTIMA polymer.
Designed and manufactured on a patient-by-patient basis, Kelyniam CSI rely on the strength, bone-like modulus, radiolucency, purity, versatility of the material, says Invibio.
A wide range of commercially available fixation systems can be used to attach the CSI to native bone, enabling surgeons to use their preferred fixation device. Because each CSI is created on 3D software and can be surgeon modified before the design is cut, the resulting implant is closely fitted to the defect. Further surgeon modifications are generally not needed and, according to American Journal of Engineering and Applied Sciences operating room time can be reduced by as much as 85% with customised skull implants.
|