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First Orthopedic Implant Using Carbon Fiber-Reinforced PEEK-OPTIMA® Polymer Approved for Use in Japan Implants using Invibio's PEEK-OPTIMA polymers continue to receive regulatory approval in Japan's complex and highly regulated medical device market. San Diego, CA (PRWeb) February 17, 2007 -- Invibio®, a leading global provider of biomaterial solutions to the medical device market, today announced that the first implantable medical device using the company's carbon fiber-reinforced (CFR) PEEK-OPTIMA® compound has received regulatory approval from the Japanese Ministry of Health, Labour and Welfare, the governing body responsible for regulating all drugs and medical devices in Japan.
The spinal implant represents the second Japanese regulatory approval of an orthopedic device using Invibio implantable biomaterials. In 2005, an arthroscopy device using unfilled PEEK-OPTIMA polymer was approved in Japan; it has been commercially available for more than 18 months.
Invibio is dedicated to the advancement of medical device technology and continually collaborates with a global network of industry resources, including medical device manufacturers, processors and research institutions, on the development of advanced biomaterials, processes and data.
Such partnerships allow Invibio to provide medical device manufacturers with advanced technical research and proven market expertise across a wide range of medical device applications. By collaborating directly with medical device manufacturers, Invibio helps them to develop superior medical devices and procedures that enhance patients' quality of life.
Invibio's regulatory expertise and experience also helps medical device manufacturers navigate time-consuming approval processes, enabling device manufacturers to accelerate time to market.
About Invibio Invibio® is a global leader providing high performance biomaterials, advanced technical research and consultative solutions to medical device manufacturers across a wide range of markets. The company provides medical device manufacturers with PEEK-OPTIMA® polymer and compounds, ENDOLIGN™ composite and PEEK-CLASSIX™ polymer for the development of long- and short-term implantable medical devices.
For more information, please contact Invibio at: 866 468 4246 or +484 342 6004 (U.S.), +44 (0) 1253 898000 (U.K.), +852 2366 4448 (Asia Pacific) or online at www.invibio.com.
For more Invibio information, press only: Tracy Conger, HSR Business to Business, (513) 346-5557
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