KFDA Acceptance of OXPEKK-IG Implantable Polymer
(PRWEB) July 8, 2010 -- Oxford Performance Materials (OPM) is very pleased to announce that the firm’s OXPEKK-IG long-term implantable polymer has been accepted by the Korean Food and Drug Administration (KFDA). The KFDA approved the Viking interspinous spinal device made by OPM’s customer Sintea Plustek.
Acceptance by the KFDA effectively opens the Korean market for Sintea Plustek and is at the same time a major milestone for OPM. “Gaining regulatory approval for our products requires long-term commitment and focus,” said Scott DeFelice, President and CEO of OPM. “With broad acceptance of OXPEKK-IG in Europe and South America, we are delighted that our Asian strategy is now moving to a commercial phase.” OPM has numerous maturing developments in the Korean market and this approval is expected to have near-term commercial impact.
The Viking device produced by Sintea Plustek is, according to excellent reviews from leading surgeons at the Hesperia Hospital and the S. C. Ortopedia and Traumatologia in Milan, a sophisticated device with a brilliant design and optimal biochemical and biomechanical features. “Sintea has been a customer of OPM for more than four years and we find their products, organization and business approach to be very desirable,” said Franco Ronchi, Technical Manager at Sintea Plustek. “We are of course very pleased that we can now expand the markets available to us and look forward to further cooperation with OPM, which we feel enables efficient technical and commercial expansion.”
OPM’s OXPEKK-IG product is a high-performance, ultra-pure thermoplastic with properties very similar to bone. The product is polyetherketoneketone (PEKK) and is within the class of Polyaryletherketone polymers (PAEK). OXPEKK-IG has been extensively implanted worldwide. The product is supported by comprehensive ISO 10993 biocompatibility and purity data. The biocompatibility data is available directly from OPM or in the firm’s extensive FDA masterfile, without any access fees. Given the long implantation history of OXPEKK-IG products, there are now numerous clinically relevant studies available for reference.
About Sintea Plustek
Sintea Plustek was created through the merger of Sintea Biotech SPA and Plustek SRL with the purpose to improve one’s quality of life and longevity by offering innovative systems. Sintea Plustek’s products are ergonomic through minimally invasive surgical techniques, which allow a fast recovery through a lasting safe product. Through its wide range of increasingly advanced products, Sintea Plustek will fulfill each surgeon’s requirements, facilitating an ergonomic design of implants and user-friendly devices. Moreover, it is important to Sintea Plustek to support the supply of innovative systems with additional services. Sintea Plustek plays an important role in the orthopaedic market.
For additional information, please visit www.sinteaplustek.com.
Founded in March 2000, OPM has rapidly become an industry leader in the ultra-high performance thermoplastic polymers market. The firm’s versatile OXPEKK polymers are currently being used in medical, space and defense, semiconductor and industrial markets worldwide. OPM is ISO 9001:2000 and ISO 13485:2003 certified.
In February 2009 OPM was acquired by France’s leading chemicals producer, Arkema.
For additional information, please visit www.oxfordpm.com or www.arkema.com/opm.
A global chemical company and France’s leading chemicals producer, Arkema consists of three strategically related businesses: Vinyl Products, Industrial Chemicals, and Performance Products. Arkema reported sales of 5.6 billion euros in 2008. Arkema has 15,000 employees across 40 countries and six research centers located in France, the United States and Japan. With internationally recognized brands, Arkema holds leadership positions in its principal markets.
For additional information, please visit www.arkema.com
OXPEKK is a registered trademark of Oxford Performance Materials, Inc.
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