VESTAKEEP® obtains medical test report from authorized organization
Evonik’s VESTAKEEP® i-Grade PEEK recently obtained the Biocompatibility Test Report from Zhejiang Institute for the Control of Medical Devices.
Zhejiang Institute for the Control of Medical Devices is the China Food and Drug Administration (CFDA) affiliated and qualified testing center. The comprehensive test of VESTAKEEP® i-Grade PEEK followed the GB 16886 standard series. PEEK has successfully passed all related tests in vivo or in vitro, which indicate that VESTAKEEP® i-Grade PEEK is of excellent biocompatibility. The report will help Evonik’s customers to get their product approved and Evonik to further explore the applications of the product in medical field.
Traditionally, metals were the materials of choice for spinal cages and other implants in the human body, but recently the high-performance plastic polyetheretherketone (PEEK) has proven a serious and even more desirable alternative. In addition to PEEK’s excellent biostability and biocompatibility, its x-ray transparency and elasticity are unreplaceable by metals. What’s more, the elasticity of PEEK closely corresponds to that of a bone. This allows an optimal transmission of force between the implant material and the natural bone, which can in turn have a positive effect on bone healing.
The application areas of PEEK have been extended from spinal implants, dental, skull implants, heart valve, to innovative areas such as gastrointestinal stent, implantable pump and hypoglossal nerve stimulation system.
According to Dominique Straessler, Head of High Temperature Polymers, High Performance Polymers Asia, “obtaining this report allows us to enter the market in China and beyond and give our customers a valuable alternative for their material of choice.”
Now, multiple Chinese manufacturers of spinal cages have already approached Evonik and used VESTAKEEP®i-Grade PEEK in their product development and clinical.
Evonik, the creative industrial group from Germany, is one of the world leaders
in specialty chemicals. Profitable growth and a sustained increase in the value of the company form the heart of Evonik’s corporate strategy. Its activities focus on the key megatrends health, nutrition, resource efficiency and globalization. Evonik benefits specifically from its innovative prowess and integrated technology platforms. Evonik is active in over 100 countries around the world. In fiscal 2014 more than 33,000 employees generated sales of around €12.9 billion and an operating profit (adjusted EBITDA) of about €1.9 billion.
Evonik Industries has been producing specialty chemical products in the Greater China region (Mainland China, Hong Kong and Taiwan) since the late 1970’s; with wide-ranging trading relations already in place prior to this in the region. Evonik regards Greater China as one of the driving forces of the global economy and we consequently endeavour to grow our business in the region. The company now has around 3,000 employees in the Greater China region, the regional sales reached over €1.1 billion in 2014.
In so far as forecasts or expectations are expressed in this press release or where our statements concern the future, these forecasts, expectations or statements may involve known or unknown risks and uncertainties. Actual results or developments may vary, depending on changes in the operating environment. Neither Evonik Industries AG nor its group companies assume an obligation to update the forecasts, expectations or statements contained in this release.