Invibio Biomaterial Solutions, the market leader in
providing PEEK-based biomaterial solutions to medical device manufacturers
around the world, announced today that, commencing this summer, Kelyniam
Global, Inc. (KLYG) will have commercially available Custom Skull Implants
(CSI), manufactured using Invibio’s patented PEEK-OPTIMA polymer. Kelyniam, an
emerging medical device manufacturer, recently received its FDA 510(k)
clearance to market cranial implants.
Designed and manufactured on a patient-by-patient basis,
Kelyniam CSI rely on the exceptional strength, bone-like modulus, radiolucency,
purity, versatility and guaranteed supply of high quality PEEK-OPTIMA
polymer. The Kelyniam CSI is intended to
correct or replace bony voids in the cranial skeleton caused by trauma or birth
defects while promoting a better anatomic fit versus conventional
reconstruction methods and materials.
Invibio’s PEEK-OPTIMA polymer features:
- Over a decade of implantation history and use in nearly 3
million implanted devices
- Natural radiolucency and compatibility with medical imaging techniques to allow
healing site visualization without artifacts
- Bone-like mechanical properties, exceptional strength and excellent durability
“We chose PEEK-OPTIMA because the product has a long safety
record, is compatible with our manufacturing environment and is consistently
available on short notice should our customers demand it,” said James Ketner,
Kelyniam president & CEO.
Streamlined CAD/CAM design and PEEK-OPTIMA processing
techniques enables Kelyniam to deliver patient-specific implants in as little
as 24 hours from the receipt of CT scans, thus significantly shortening the
time between trauma and implantation. Less waiting time means healing can begin
more quickly, promoting greater patient satisfaction, shorter hospital stays
and minimizing the potential need for subsequent hospital admissions.
A wide range of commercially available fixation systems can
be used to attach the Kelyniam CSI to native bone, enabling surgeons to use
their preferred fixation device. Because each Kelyniam 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 customized skull implants.