Implants made from the PEEK-Optima HA Enhanced implantable polymer have received their first CE mark (European) approval. This has been granted to implants supplied by the Karmed Saglik Group for the treatment of degenerative spinal conditions.
Granted specifically for Karmed's Superfusion line of spinal implants, which focuses on interbody cages for therapeutic use in the cervical and lumbar areas, all implants in this product line are now produced using PEEK-Optima HA Enhanced.
"We selected this polymer because it pushes past the traditional boundaries of bone on-growth," said Gamze Yildrim, business development manager at the Karmed Group.
"We have been aware for some time that it is an exceptional performer in spinal fusion scenarios, enabling early and direct bone apposition. In fact it has many virtues, including radiolucency, enabling monitoring of the implant in a way that is just not possible with titanium implants."
PEEK-Optima HA Enhanced shares all of the material properties that originally made PEEK- Optima Natural the material for spinal interbody fusion devices, including a modulus similar to that of bone, radiolucency, biocompatibility and long-term stability. It has been compounded with hydroxylapatite (HA), an osteoconductive material that enhances bone apposition. 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.
"PEEK- Optima HA Enhanced is on its way to becoming the material of choice for spinal fusion implants," noted Michael Veldman, global strategic marketing manager at Invibio.
"This is not just a case of pre-market trialing. This latest news from the Karmed Group is positive proof that our enhanced polymer is now ready for commercial application. We are confident that it will have a positive impact on the quality of life of patients with clinical spinal conditions."
The increasing adoption of Invibio's PEEK- Optima HA Enhanced has also been seen outside of Europe following news that medical device maker SpineFrontier has been granted 510k approval by the US Federal Drug Administration (FDA) for the use of the polymer in a spinal implant.