Nanophase materials for orthopedic implant applications. (1) ISO/TS 80004-1:2015(en): Nanoscale-length range approximately Produce a nanotextured topography into the surface of a PEEK interbodyĭevice has the potential to set a new standard in the performance of That drive bone growth required for a solid fusion. Shown that nanoscale surface topographies generate osteogenic responses Spine and potentially for other orthopedic applications. Leadership in developing advanced nano-processing technology for the It is an important demonstration of Vallum's Interbody fusion device incorporating nanotechnology is a tremendous Woodard, M.D., chairman of Vallum's Medical Advisoryīoard, commented, "Receiving the first FDA clearance for a PEEK Techniques and protocols used to produce PEEKplus."Įric J. Proprietary ANAB processing technology as well as the nano-processing Investment in time and capital has been made in developing our Researchers, ion beam scientists, and biomedical engineers," said Surgery and the result of a collaborative effort among surgeons, "Our PEEKplus is a breakthrough innovation in spinal fusion Interbody device-only now, it's differentiated in the spine market Interbody device without altering its design or size, and withoutĪffecting mechanical or chemical properties. Technology can be inexpensively applied to any fully manufactured PEEK While this FDA clearance is specific to Vallum, its nanotexturing Significant step down that very promising path." Modification at the nano-scale, and Vallum's FDA clearance is a The most important of those technological advances is surface Edelman, M.D., Ph.D., who provided the earliest advice andĮncouragement to Vallum's management team. Implantable medical devices are taking many forms," said Prof.Įlazer R. "Technological advances to improve the performance of PEEKplus is not a coating, it is not porous, and no chemicals are Osteoblast functions that are necessary to grow bone and promote fusion. Nanotexturing below 100 nanometers has been shown to be beneficial to PEEK device to create the nanotexture of PEEKplus. The impact of argon atoms across the entire existing microsurface of the Nanoscale concavities of 20-50 nanometers are created by Vallum's PEEKplus nanotextured surface is unique in the spinalĭevice market. PEEKplus is the first and only FDA-cleared nanotextured surface on Intervertebral spinal fusion cages have been widely used in spinal surgery since their. PEEK-plus nanotextured (1) surface created by Vallum's proprietaryĪnd patented Accelerated Neutral Atom Beam (ANAB) technology. Polyether ether ketone (PEEK) spinal interbody fusion device with a Food and Drug Administration (FDA) to market a This report provides: 1) An overview of the global market for Spinal Fusion Market. Vallums in vitro and in vivo studies have shown its subtractive nanotexturing on PEEK significantly increases. This icon displays Vallum status: black when firewall is enabled and greyed-out when firewall is disabled. There you can enable/disable the firewall or change firewall configuration. Vallum Corporation, a medical device company, has receivedĬlearance from the U.S. Spinal fusion devices are used for the treatment of spinal deformities like chronic disc disease and dislocation. Devices for Spinal Intervertebral Fusion. Vallum is always on and can be controlled from Vallum Agent, that is the menulet icon in macOS menu bar, near the clock.
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