DiFusion Technologies' ALIF Implant Gains FDA Clearance
Xiphos ALIF (anterior lumbar interbody fusion), a spinal implant developed by DiFusion Technologies, has received U.S. Food and Drug Administration’s (FDA) 510(k) clearance for use in interbody fusion devices devices. The implant is made out of a high-performance PEEK (polyetheretherketone) polymer, Vestakeep, made by Evonik Industries.
“This milestone helps pave the way for more innovative medical devices developed from bioactive polymers,” said Derrick Johns, CEO of DiFusion Technologies. “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. “This marks the second product line DiFusion is using Vestakeep PEEK for and demonstrates the strong relationships necessary for success in this space.”
According to DiFusion, Vestakeep PEEK is characterized by its superior biocompatibility and biostability making it suitable as a raw material used in the development of medical devices. The polymer is touted to have excellent sterilization resistance and good combination of stiffness and ductility make it optimal for use in spinal implants that must meet extremely high mechanical, thermal, and chemical requirements.
DiFusion Technologies is based in Georgetown, Texas, and makes advanced biomaterials for medial devices.
Evonik is a specialty chemicals company based in Germany.