Thornton Cleveleys (UK) – The next implants made from the PEEK-OPTIMA™ HA Enhanced implantable polymer have received the CE mark (European) approval. The CE mark is necessary for distributing products within the European Free Trade Association (EFTA) and the European Union. Following the Class IIb approval route a CE mark has now been granted to implants supplied by the Turkey-based company Osimplant for the treatment of degenerative disc spinal conditions.
Osimplant’s Cervical Expandable Bladed HA PEEK Cage line of spinal implants, offered under the Arion brand name, is the second line of implants that has received the European approval since December. The interbody cages, designed to promote spinal fusion and healing, were successfully developed using PEEK-OPTIMA HA Enhanced, a strong, versatile biomaterial based on PEEK-OPTIMA polymer compounded with hydroxyapatite (HA), a well-known osteoconductive material for enhancing bone apposition.
The innovative PEEK-OPTIMA HA Enhanced, offered by Invibio Biomaterial Solutions (“Invibio”), has similar mechanical properties to PEEK-OPTIMA Natural and a modulus similar to that of cortical bone. The introduction of HA, which is fully integrated into the PEEK-OPTIMA Natural grade, provides a complete homogeneous compound that ensures HA is present at all surfaces of a device. Like PEEK-OPTIMA Natural, PEEK-OPTIMA HA Enhanced is radiolucent, allowing visualization of the fusion mass, and has proved to be fully biocompatible.
“We have chosen PEEK-OPTIMA HA Enhanced because it is an excellent polymer that has demonstrated its performance in pre-clinical studies, with superior new bone formation and quality of new bone bridging compared with PEEK-OPTIMA Natural at early time points. 1 In 2015 we will complete our cage family (TLIF, PLIF, ACIF) using PEEK-OPTIMA HA Enhanced, as we strongly believe that this will help us to significantly improve our share in the European spine market.” said Özcan Karadag, General Manager at Osimplant.
A previous study that evaluated the bone on-growth of the two implantable polymers in a bone defect model in sheep, revealed that PEEK-OPTIMA HA Enhanced resulted in approximately 75% direct bone apposition as early as four weeks following implantation.2
The increasing adoption of Invibio’s PEEK-OPTIMA HA Enhanced has also been observed outside Europe, following news in November that medical device maker SpineFrontier™ achieved 510(k) clearance from the US Federal Drug Administration (FDA) for the use of the polymer in a spinal implant.
Osimplant’s Cervical Expandable Bladed HA PEEK Cage line of spinal implants based on PEEK OPTIMA HA Enhanced from Invibio receives European approval.
Invibio™, a Victrex plc company, is a global leader in providing high performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic medical segments for the development of long implantable medical devices. Today, Invibio’s PEEK-OPTIMA™ polymers are used in more than five million implanted devices worldwide.
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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