Tuesday, July 24, 2018
Medical device company Vallum Corporation today 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 .
PEEKplus® is the first and only FDA approved PEEK interbody device nanotextured surface.
Vallum's PEEKplus® nanotextured surface is unique in the spine instrument market. The argon atom bombards the 20-50 nanometer concave surface of the entire PEEK micron-scale surface to form the nano-texture of PEEKplus®. Importantly, studies have shown that nanotextures below 100 nm are beneficial for osteoblast function, which is required for bone growth and promotion of fusion.
PEEKplus is not a coating , nor a porous structure , and no chemicals are injected into PEEK.
Professor Elazer R. Edelman, MD, PhD first advised and encouraged the Vallum management team. “There are many forms of technological advances in improving the performance of implantable medical devices. I believe that one of the most important of these technologies is nanoscale. Surface treatment, Vallum's approval by the FDA is an important step on this promising road."
Although 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. The PEEK interbody device is identical, but now with PEEKplus® nanotexture, there is a real difference in the spine market.
Stephen M. 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. We have invested a lot of time and money in proprietary ANAB process technology and nanotechnology for PEEKplus®."
Eric J. 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. It shows that it is being developed for spine and other potential orthopedics. Vallum has a leading position in the field of advanced nanotechnology for applications. Studies have shown that nanoscale surface topological textures can form an osteogenic response that drives the bone growth required for robust fusion. 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."
