Vallum Corp said today it won FDA 510(k) clearance for its PEEKplus nanotextured spinal interbody fusion device, touting it as the first nanotextured PEEK interbody device to win an FDA nod.
The Nashua, N.H.-based company’s PEEKplus nanotextured surface features nano-scale concavities of between 20 and 50 nanometers created by the impact of argon atoms across the existing PEEK microsurface. Vallum said that such nanotexturing below 100 nanometers has been shown to benefit osteoblast functions necessary to grow bone and promote fusion.
“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 nano-scale 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,” medical advisory board chair Dr. Eric Woodard said in a prepared statement.
Vallum said that its nanotexturing technology can be applied to any fully manufactured PEEK interbody device without affecting design or size.
“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. 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,” prez & CEO Stephen Blinn said in a press release.