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FDA OKs First Nanotechnology PEEK Devices for Spinal Intervertebral Fusion.

Vallum Corporation, a medical device company, has received clearance from the U.S. Food and Drug Administration (FDA) to market a polyether ether ketone (PEEK) spinal interbody fusion device with a PEEK-plus nanotextured (1) surface created by Vallum's proprietary and patented Accelerated Neutral Atom Beam (ANAB) technology.

PEEKplus is the first and only FDA-cleared nanotextured surface on a PEEK interbody device.

Vallum's PEEKplus nanotextured surface is unique in the spinal device market. Nanoscale concavities of 20-50 nanometers are created by the impact of argon atoms across the entire existing microsurface of the PEEK device to create the nanotexture of PEEKplus. Importantly, nanotexturing below 100 nanometers has been shown to be beneficial to osteoblast functions that are necessary to grow bone and promote fusion. (2,3)

PEEKplus is not a coating, it is not porous, and no chemicals are infused into the PEEK.

"Technological advances to improve the performance of implantable medical devices are taking many forms," said Prof. Elazer R. Edelman, M.D., Ph.D., who provided the earliest advice and encouragement to Vallum's management team. "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."

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. It's the same PEEK interbody device--only now, it's differentiated in the spine market with a PEEKplus nanotexture.

"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. Blinn, president and CEO of 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."

Eric J. 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. It is an important demonstration of Vallum's leadership in developing advanced nano-processing technology for the spine and potentially for other orthopedic applications. It has been shown that nanoscale surface topographies generate osteogenic responses that drive bone growth required for a solid fusion. 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."

References

(1) ISO/TS 80004-1:2015(en): Nanoscale-length range approximately from 1 nm to 100 nm.

(2) Ganesan Balasundaram and Thomas J. Webster. A perspective on nanophase materials for orthopedic implant applications. Journal of Materials Chemistry, Issue 38, 2006.

(3) Gabriel Colon. Brian C. Ward, Thomas J. Webster. Increased osteoblast and decreased Staphylococcus epidermidis functions on nanophase ZnO and TiO2. Published online 2 June 2006 in Wiley InterScience. DOI: 10.1002/jbm.a.30789.
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Title Annotation:News Front
Publication:Orthopedic Design & Technology
Date:Jul 1, 2018
Words:500
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