"We are determined to work with medical device manufacturers in a manner that is most cost-effective for them and supports them in providing reliable, proven solutions to surgeons quickly."
Thornton Cleveleys (UK) (PRWEB) November 09, 2015
An innovative high-performance polymer for spinal fusion implants, PEEK-OPTIMA® HA Enhanced, which enables early and direct bone apposition, has now passed biocompatibility testing in China.1 This paves the way for approval by the China Food and Drug Administration (CFDA) and local legal compliance, as confirmed in the Regulatory Affairs (RA) clearance process. In Europe and the USA, medical device manufacturers are already offering a new generation of implants based on this superior material. PEEK-OPTIMA HA Enhanced is available from Invibio Biomaterial Solutions ("Invibio"), a Victrex plc company, the world leading provider of proven PEEK-based biomaterial solutions.
Invibio's PEEK-OPTIMA HA Enhanced polymer is an implantable material that uniquely combines two clinically-proven advanced biomaterials for enhanced bone apposition: PEEK-OPTIMA, the principal PEEK-based biomaterial from Invibio that has over 15 years of proven history in clinical use, and hydroxyapatite (HA), a well-known and proven osteoconductive material.
Biocompatibility testing of PEEK-OPTIMA HA Enhanced has been successfully completed, in China, at CFDA Tianjin Medical Device Supervision and Testing Center. The associated results are available in reports released on Delayed Type Hypersensitivity, Skin Irritation, Genotoxicity, Systematic toxicity, In-vitro cytotoxicity, Sub-chronic toxicity and 26 week bone implantation.
Successful passing of the '26 week bone implantation test', which assesses the bone implantation process at 26 weeks, is particularly significant because it will reduce the time involved in the application process, when medical device manufacturers seek CFDA approval.
Implant devices made of the novel PEEK-OPTIMA HA Enhanced have already been cleared by regulatory bodies in both Europe (CE mark approval) and the US (510(k) clearance) for cervical and lumbar cages. Among the clearances granted:
- SpineFrontier™ for the use of PEEK-OPTIMA HA Enhanced in its Arena-C HA cervical interbody fusion device (October, 2014)
- Meditech Spine for the use of PEEK-OPTIMA HA Enhanced for its next generation of cervical intervertebral fusion devices (April, 2015)
- Cutting Edge Spine for its EVOS system of lumbar interbody implants (July, 2015)
Reliable and proven solutions supporting quick market entry in China
"Invibio is absolutely committed to building our activities in China and extending our portfolio of implantable polymers to this fast developing market, where there is high demand for innovative solutions in just about every medical sector", commented John Devine, Medical Business Director. "We are determined to work with medical device manufacturers in a manner that is most cost-effective for them and supports them in providing reliable, proven solutions to surgeons quickly."
PEEK-OPTIMA HA Enhanced shares all of the material properties that originally made PEEK-OPTIMA Natural the leading material for spinal interbody fusion devices. In China the CFDA has granted more than 80 approvals for implantable devices made of PEEK OPTIMA Natural. In addition to interbody fusion devices these include CMF plates in neurosurgery, interference screws and bone fixation anchors for sports medicine – all of which have been used as long-term implantations.
Benefits of PEEK-OPTIMA HA Enhanced include a modulus similar to that of bone, radiolucency and artifact-free imaging, whether by X-ray, MRI or CT scanning, allowing visual assessment of the fusion mass, biocompatibility and long-term stability. Hydroxyapatite (HA), a natural constituent of human bone, enhances bone apposition on all the surfaces of a spinal implant and eliminates the time and expense of applying coatings.
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.2
Invibio at COA 2015
Invibio will be participating in COA 2015, the 10th International Congress of the Chinese Orthopaedic Association, 19-22 November, 2015, in Chongqing. The venue for this year's show, where Invibio will be showcasing its portfolio of world-leading biomaterial solutions, including PEEK-OPTIMA HA Enhanced, is the Chongqing Yuelai International Convention and Exhibition Center, where Invibio will be at hall N3 booth no. 3S22.
For more information about PEEK-OPTIMA HA Enhanced, please visit http://www.invibiospine.com
1. The formal report will soon be available.
2. 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, 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.
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 delivering leading edge solutions to shape future performance for our customers and our markets, and to drive value for our shareholders. Find out more at http://www.victrexplc.com