VESTAKEEP® PEEK-Based Spinal Implant Receives FDA 510(k) Approval
DiFusion Technologies' Xiphos™ ALIF Gains Interbody Fusion Device Clearance
PARSIPPANY, N.J.--(BUSINESS WIRE)-- Xiphos™ ALIF, a VESTAKEEP® PEEK-based (polyetheretherketone) spinal implant developed by DiFusion Technologies, has received the U.S. Food and Drug Administration's (FDA) 510(k) approval for use in Interbody Fusion Devices (IBF) devices.
"DiFusion Technologies is very excited about the FDA 510(k) approval of the VESTAKEEP® PEEK-based Xiphos™ ALIF spinal implant," said Derrick Johns, managing director of DiFusion Technologies. "This milestone helps pave the way for more innovative medical devices developed from bioactive polymers. Evonik's VESTAKEEP® PEEK's strength and ductility proved to be critical for the FDA approval and the excellent test results Xiphos™ ALIF received."
"We are pleased with the approval DiFusion received using VESTAKEEP®," said Sanjeev Taneja, vice president of Evonik's High Temperature Polymers Business. "Evonik always strives to meet the needs of its customers and helping DiFusion Technologies achieve FDA 510(k) approval for Xiphos™ ALIF is an example of our efforts. This marks the second product line DiFusion is using VESTAKEEP® PEEK for and demonstrates the strong relationships necessary for success in this space."
VESTAKEEP® PEEK is characterized by its superior biocompatibility and biostability making it suitable as a raw material used in the development of medical devices. Its excellent sterilization resistance and good combination of stiffness and ductility make it excellent for use in spinal implants that must meet extremely high mechanical, thermal, and chemical requirements.
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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 2012 more than 33,000 employees generated sales of around €13.6 billion and an operating profit (adjusted EBITDA) of about €2.6 billion.
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