Implants made from the PEEK-OPTIMA® HA Enhanced implantable polymer have received their first CE mark (European) approval. It is granted to implants supplied by the Karmed Saglik Group ("Karmed") for the treatment of degenerative spinal conditions. The approval is necessary for distributing products within the European Free Trade Association (EFTA) and the European Union. The innovative PEEK-OPTIMA HA Enhanced polymer is offered by Invibio Biomaterial Solutions ("Invibio").
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 YILDIRIM, 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PEEK-OPTIMA HA Enhanced shares all of the material properties that originally made PEEK-OPTIMA Natural the leading material for spinal interbody fusion devices, including a modulus similar to that of bone, radiolucency, biocompatibility and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), a well-known 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.*
19-Dec-14 
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