PEEKplus has arrived.
The FDA granted Vallum Corporation a 510(k) clearance for its proprietary and patented Accelerated Neutral Atom Beam (ANAB) technology for creating nanotextured surfaces on a PEEK (polyetheretherketone) interbody device.
It took the FDA a little over six months to make their decision. The company claims it is the “first and only” FDA-cleared nanotextured surface on a PEEK interbody device, according to a July 17, 2018 announcement by the Nashua, New Hampshire-based company.
The company says its proprietary and patented ANAB technology is not a coating, is not porous, and used no chemicals in its PEEK construct. The nanotexturing process can be achieved in one final manufacturing step.
Nanotexturing on a device, according the company, is 4 million times smaller than dimples on a golf ball.
The nanotextured surface is “unique in the spinal device market,” according to the company. “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. Importantly, nanotexturing below 100 nanometers has been shown to be beneficial to osteoblast functions that are necessary to grow bone and promote fusion.”
In addition, the company says nanotexturing changes PEEK from its natural hydrophobic state to hydrophilic, which is also known to improve osseointegration.
“Technological advances to improve the performance of implantable medical devices are taking many forms,” said Professor 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, the company said its nanotexturing technology can be applied inexpensively to any fully manufactured PEEK interbody device without altering its design or size, and without affecting mechanical or chemical properties.
Eric J. Woodard, M.D., Chairman of Vallum’s Medical Advisory Board, said 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.”
