Feb 19 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.