01.09.15
Implants made from Invibio’s PEEK-Optima HA Enhanced implantable polymer have received their first CE mark approval for commercialization in the European Union. The approval was granted to the Superfusion line of spinal implants provided by the Karmed Saglik Group, based in Istanbul, Turkey, for the treatment of degenerative spinal conditions. All implants in this product line are now produced using Invibio Biomateral Solutions’ 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PEEK-Optima HA Enhanced shares all of the material properties that originally made PEEK-Optima Natural, including a modulus similar to that of bone, radiolucency, biocompatibility and long-term stability.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 suggested 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 percent direct bone apposition.
“PEEK-Optima HA Enhanced is on its way to becoming the material of choice for spinal fusion implants,” said 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.”
According to Invibio, the increasing adoption of Invibio’s PEEK-Optima HA Enhanced has also been seen outside of Europe following news in November that medical device maker SpineFrontier has now been granted 510(k) clearance by the U.S. Federal Drug Administration (FDA) for the use of the polymer in a spinal implant.
Invibio Biomaterial Solutions (Invibio Inc. in the United States and Invibio Ltd. in Europe) is based in West Conshohocken, Pa. with European headquarters in Lancashire, United Kingdom.
“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, 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 suggested 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 percent direct bone apposition.
“PEEK-Optima HA Enhanced is on its way to becoming the material of choice for spinal fusion implants,” said 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.”
According to Invibio, the increasing adoption of Invibio’s PEEK-Optima HA Enhanced has also been seen outside of Europe following news in November that medical device maker SpineFrontier has now been granted 510(k) clearance by the U.S. Federal Drug Administration (FDA) for the use of the polymer in a spinal implant.
Invibio Biomaterial Solutions (Invibio Inc. in the United States and Invibio Ltd. in Europe) is based in West Conshohocken, Pa. with European headquarters in Lancashire, United Kingdom.