The FDA’s clearance of the first device containing this unique material is a monumental achievement for both SpineFrontier and Invibio and gives SpineFrontier a significant advantage with the first approved device to market using this new technology.
San Francisco, CA (USA) and Thornton Cleveleys (UK) (PRWEB) November 07, 2014
Invibio Biomaterial Solutions ("Invibio") will reveal the results of a new study on the use of PEEK-OPTIMA HA Enhanced in spinal fusion at 2014 North American Spine Society (NASS) annual meeting in San Francisco, November 12-15. This medical-grade PEEK polymer was developed to encourage high quality bone growth directly against all implant surfaces and is now primed to be the new gold standard for interbody fusion devices following the first 510(k) clearance of a spinal device containing the polymer
During a featured “NASS Solutions Showcase,” Professor Bill Walsh of the University of New South Wales will present the latest research findings from a preclinical cervical fusion study to spine surgeons and spinal implant suppliers. Professor Walsh's new study compares the mechanical properties and fusion results achieved in a cervical spine model with PEEK-OPTIMA HA Enhanced, PEEK-OPTIMA Natural, the current standard in spinal fusion cage technology, and allograft bone.
The presentation will take place at 12:00 pm on Wednesday, November 12, in the Solution Showcase Theater (Booth #2504) on the NASS exhibition floor.
The recent 510(k) clearance of SpineFrontier’s Arena-C HA cervical interbody fusion device, which is composed of PEEK-OPTIMA HA Enhanced, is evidence that device manufacturers are making investments in this new material platform and that surgeons see the benefits of having hydroxyapatite available at the implant surface in addition to having all the traditional benefits of PEEK-OPTIMA based devices.
Michael Veldman, Global Strategic Marketing Manager at Invibio stated, "The FDA’s clearance of the first device containing this unique material is a monumental achievement for both SpineFrontier and Invibio and gives SpineFrontier a significant advantage with the first approved device to market using this new technology. The data being presented at NASS will provide additional evidence to support why PEEK-OPTIMA HA Enhanced is being viewed as the next material standard for interbody spinal fusion devices."
Visitors to NASS are welcome to discuss this and other developments with Invibio representatives at Booth #1714.
For more information about PEEK-OPTIMA HA Enhanced, please visit TurbochargeFUSION.com.
For more infomation about NASS 2014, please visit http://www.spine.org/AM/Pages/NASS2014.
*Pre-clinical study in ovine model. Data on file at Invibio. This has not been correlated with human clinical experience.
About Invibio Biomaterial Solutions
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, aeroplanes 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 http://www.victrexplc.com