Thornton Cleveleys (UK), December 16, 2014 – 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PEEK-OPTIMA HA Enhanced shares all of the material properties that originally made PEEK-OPTIMA Natural the leading material for spinal interbody fusion devices, including a modulus similar to that of bone, radiolucency, biocompatibility and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.*
“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 in November that medical device maker SpineFrontier™ has now been granted 510k approval by the US Federal Drug Administration (FDA) for the use of the polymer in a spinal implant.
* Pre-clinical study in ovine model. Data on file at Invibio. This has not been correlated with human clinical experience.
Invibio™, a Victrex plc company, has grown significantly since pioneering PEEK biomaterial in 1999, evolving from a materials supplier to an industry-leading provider of biomaterial solutions. During that time the company has worked with world class research institutions, to develop and commercialize six implantable PEEK grades. Today, Invibio’s PEEK-OPTIMA™ polymers are used in more than four million implanted devices worldwide. About Victrex plc Victrex, headquartered in the UK, is an innovative world leader in high performance polymer solutions focused on the Aerospace, Automotive, Electronics, Energy and Medical markets. Every day, millions of people rely on products or applications which contain our polymers, from smartphones, airplanes and cars to oil & gas operations and medical devices. With over 35 years’ experience, we are investing in technical excellence to deliver leading edge solutions to our customers and our markets, and to drive value for our shareholders. Find out more at www.victrexplc.com
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