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If nanoscale can be drawn on the surface of the PEEK interbody device The texture topology will hopefully set a new standard for the performance of spinal fusion interbody implants. Studies have shown that nanoscale surface topological textures can form an osteogenic response that drives the bone growth required for robust fusion. Vallum has a leading position in the field of advanced nanotechnology for applications.

It shows that it is being developed for spine and other potential orthopedics. Woodard, MD, chairman of the Vallum Medical Advisory Board, commented: “The first FDA approval for the integration of nanotechnology PEEK interbody fusion devices is an important milestone for Vallum. We have invested a lot of time and money in proprietary ANAB process technology and nanotechnology for PEEKplus.”Įric J. Blinn, President and CEO of Vallum, said: “Our PEEKplus is a breakthrough innovation in spinal fusion surgery and a result of collaborative efforts between surgeons, researchers, ion beam scientists, and biomedical engineers. The PEEK interbody device is identical, but now with PEEKplus nanotexture, there is a real difference in the spine market. Surface treatment, Vallum’s approval by the FDA is an important step on this promising road.”Īlthough the FDA approval is for Vallum, its nanotexturing technology can be applied to any fully manufactured PEEK interbody device at a lower cost without changing its design or size without affecting mechanical or chemical properties. I believe that one of the most important of these technologies is nanoscale.

“There are many forms of technological advances in improving the performance of implantable medical devices.

Edelman, MD, PhD first advised and encouraged the Vallum management team. PEEKplus is not a coating, nor a porous structure, and no chemicals are injected into PEEK. Importantly, studies have shown that nanotextures below 100 nm are beneficial for osteoblast function, which is required for bone growth and promotion of fusion. The argon atom bombards the 20-50 nanometer concave surface of the entire PEEK micron-scale surface to form the nano-texture of PEEKplus. Vallum’s PEEKplus nanotextured surface is unique in the spine instrument market. PEEKplus is the first and only FDA approved PEEK interbody device nanotextured surface. Medical device company Vallum Corporation announced that the US Food and Drug Administration (FDA) has approved a polyetheretherketone (PEEK) spine vertebral body Inter-fusion device that uses the PEEKplus nanotextured surface drawn by Vallum’s proprietary and patented accelerated neutral atomic beam (ANAB) technology.

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Vallum medical trial#

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