FDA clears first nanotechnology PEEK devices for spinal intervertebral fusion

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nanotechnologyThe US Food and Drug Administration (FDA) has granted approval to market a polyetheretherketone (PEEK) spinal interbody fusion device with a PEEKplus nanotextured surface (Vallum Corporation). The PEEKplus nanotextured surface is the first and only FDA-cleared nanotextured surface on a PEEK interbody device, and is created by Vallum’s proprietary and patented Accelerated Neutral Atom Beam (ANAB) technology. nanotechnology

Nano-scale concavities of 20–50 nanometres 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 nanometres has been shown to be beneficial to osteoblast functions that are necessary to grow bone and promote fusion. nanotechnology

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

“Technological advances to improve the performance of implantable medical devices are taking many forms,” says Elazer R Edelman (Boston, USA), 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.

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