Vallum’s mission is to develop, produce and deliver innovative and disruptive nano-scale surface technologies to affordably improve implantable medical devices and thereby improve patient outcomes and quality of life. Accelerated Neutral Atom Beam (ANAB) technology and its medical applications for nano-scale surface modification, including PEEKplus, are covered by multiple issued patents and trade secrets. The company’s management believes its advanced technology and processing protocols can ultimately be developed to improve other implantable orthopedic devices for treating disorders throughout the body. The company is currently focused on nano-scale surface modification of PEEK interbody fusion devices to improve their performance in spinal fusion. It has developed advanced technology and processing protocols for nano-scale surface engineering of implantable medical devices. Professor and Vice Chairman of the Department of Orthopedics. Vallum is a medical device company headquartered in Nashua, New Hampshire. University of Utah School of Medicine, Salt lake City, UT. The ability to produce a nanotextured topography into the surface of a PEEK interbody device has the potential to set a new standard in the performance of spinal fusion interbody implants.”
It has been shown that nano-scale surface topographies generate osteogenic responses that drive bone growth required for a solid fusion. It is an important demonstration of Vallum’s leadership in developing advanced nano-processing technology for the spine and potentially for other orthopedic applications. Woodard, M.D., chairman of Vallum’s Medical Advisory Board, commented, “Receiving the first FDA clearance for a PEEK interbody fusion device incorporating nanotechnology is a tremendous milestone for Vallum. “A substantial investment in time and capital has been made in developing our proprietary ANAB processing technology as well as the nano-processing techniques and protocols used to produce PEEKplus.”Įric J. “Our PEEKplus is a breakthrough innovation in spinal fusion surgery and the result of a collaborative effort among surgeons, researchers, ion beam scientists, and biomedical engineers,” said Stephen M. Exact same PEEK interbody device – only now, truly differentiated in the spine market with a PEEKplus nanotexture. While this FDA clearance is specific to Vallum, its nanotexturing technology can be inexpensively applied to any fully manufactured PEEK interbody device without altering its design or size, and without affecting mechanical or chemical properties. “I believe one of the most important of those technological advances is surface modification at the nano-scale, and Vallum’s FDA clearance is a significant step down that very promising path.” Edelman, MD, PhD, who provided the earliest advice and encouragement to Vallum’s management team.
“Technological advances to improve the performance of implantable medical devices are taking many forms,” said Prof. PEEKplus is not a coating, it is not porous, and no chemicals are infused into the PEEK. Importantly, nanotexturing below 100 nanometers has been shown to be beneficial to osteoblast functions that are necessary to grow bone and promote fusion. Nano-scale concavities of 20-50 nanometers are created by the impact of argon atoms across the entire existing microsurface of the PEEK to create the nanotexture of PEEKplus. Vallum’s PEEKplus nanotextured surface is unique in the spinal device market. PEEKplus is the first and only FDA-cleared nanotextured surface on a PEEK interbody device. Vallum Corporation, a medical device company, has received clearance from the US Food and Drug Administration (FDA) to market a polyetheretherketone (PEEK) spinal interbody fusion device with a PEEKplus nanotextured surface created by Vallum’s proprietary and patented Accelerated Neutral Atom Beam (ANAB) technology. Vallum's spinal interbody fusion device PEEKplus Nanotexturing receives US FDA approval The other authors have noĬopyright 2020 Elsevier B.V., All rights reserved.You can get e-magazine links on WhatsApp. T1 - The university of miami spine surgery ERAS protocolĬonflicts of Interest: MY Wang: Recipient of royalty payments from DePuy-Synthes Spine, Inc., Children’s Hospital of Los Angeles, Springer Publishing, and Quality Medical Publishing consultant for DePuy-Synthes Spine, Inc., Stryker Spine, K2M, and Spineology advisory board member for Vallum stock in Spinicity and Innovative Surgical Devices and Awardee of grants from the Department of Defense.
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