An established strategic partnership between Beijing Fule and Invibio Biomaterial Solutions has resulted in the development of a new generation of interbody fusion devices, the first such high performance material medical fusion cage product based upon PEEK-OPTIMATM HA Enhanced polymers in China.
Beijing Fule has achieved a milestone regulatory clearance by China NMPA (National Medical Products Administration) for its new devices with the innovative PEEK-OPTIMATM HA Enhanced polymer. Due for launch in August, 2022, the new generation of devices are designed to improve the performance of the spinal cage by enabling the full device to actively participate in the spinal fusion process due to the incorporation of hydroxyapatite crystals throughout the device.
Explains Mr. Guo Ping Fan, Deputy General Manager and Director of R&D at Beijing Fule, “Our partnership with Invibio has always been a fruitful one, and we place great value on what PEEK-based materials can bring to our development of high-performance orthopaedic products. We are excited about the potential of this new spinal interbody fusion devices which are the 1st China NMPA approved spine cages made with innovative PEEK-OPTIMATM HA Enhanced polymer. We are very confident that the new devices will significantly improve the clinical outcomes and bring good benefits to patients.”
Based upon PEEK-OPTIMATM HA Enhanced, the new generation of interbody fusion devices from Beijing Fule will make use of the high mechanical strength of the polymer, along with its X-ray permeability for intraoperative examination, high stability, enhanced bone apposition1 , and elastic modulus close to that of cortical bone.
Says John Devine, Business Unit Director, Invibio Biomaterial Solutions, “The strong cooperation of both Beijing Fule and Invibio’s regulatory teams has successfully accelerated the market launch of devices that have the potential to change the quality of life for spinal patients in China. PEEK-OPTIMA™ devices have been used in interbody fusion devices in China for decades, and in implantable medical devices in general, and has been shown to provide better outcomes than using titanium alone in spinal fusion surgery. Fully integrating osteoconductive hydroxyapatite into the matrix of PEEK OPTIMATM polymer results in a strong, versatile and a highly effective biomaterial that lends itself well to bone apposition cases.” Benefits of using PEEK-OPTIMATM HA Enhanced in such medical applications include enhanced bone apposition1, material modulus close to bone, radiolucency on x-ray and artifact free imaging on CT and MRI.
Based on the high stability of the material, the high fatigue strength can provide strong support for degenerative spinal discs, maintain intervertebral space height and increase stability, reducing stress shielding on the contact surface and the probability of anti-subsidence and prolapse.
Dr. Jin Cai. Yang from Beijing ChaoYang Hospital, Capital Medical University comments, “Spinal surgery is obviously a highly specialised branch of medicine, with a number of inherent safety issues that can influence a patient’s long-term prognosis. Simply, the use of advanced and tailored polymer materials brings many benefits to patients. Advancements in technologies using devices based on materials such as PEEK-OPTIMATM HA Enhanced is very positive, and the potential for improved outcomes for many patients in China is very encouraging.”
Reference: [1] Study evaluated the bone on-growth of PEEK-OPTIMATM Natural and PEEK-OPTIMATM HA Enhanced in a bone defect model in sheep. Data on file at Invibio. This has not been correlated with human clinical data.
About Beijing Fule Science & Technology Development Co., LTD.
Established in 1996, Beijing Fule Science & Technology Development Co. Ltd is one of leading manufacturer of Orthopaedic products including spinal products, trauma products and related instruments. The company's products have been widely used by thousands of large and medium-sized hospitals and achieved a good report, winning a high reputation from many orthopedic experts. Further information is available on www.fulekeji.com
About Invibio Biomaterial Solutions
Invibio, part of the Victrex plc group of companies, 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 and dental medical segments for the development of long-term implantable medical devices. Today, Invibio’s PEEK-OPTIMA polymers are used in approximately 15 million implanted devices worldwide. Learn more at www.invibio.com.
About Victrex plc
Victrex is an innovative world leader in high performance PAEK/PEEK polymer solutions, focused on the strategic markets of automotive, aerospace, energy (including manufacturing & engineering), electronics and medical. Every day, millions of people use products and applications which contain our materials – from smart phones, airplanes and cars to oil and gas operations and medical devices. With 40 years’ experience, we develop world leading solutions in PEEK and PAEK-based polymers and selected semi-finished and finished parts which shape future performance for our customers and our markets, and drive value for our shareholders. Find out more at www.victrex.com.
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