Eric L. Woodard, MD, the chairman of Vallum's Medical Advisory Board, was interviewed for this executive briefing to get his opinions regarding the surgeon survey as well as his perspective on the development of PEEKplus nanotexturing and its recent FDA clearance.
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Question: Dr. Woodard, do your opinions agree with those of the surgeons surveyed regarding the importance of bone bridging through the center hole of an interbody device and the importance of bony apposition at the end plates; and that four months is an early goal for both?
Dr. Eric Woodard: I certainly agree with the bulk of responses in the survey. The bone bridging through the interbody device, especially apposition at the endplates, is an important indicator of a successful fusion. I also agree bridging should occur early. The four months goal is certainly a reasonable standard. But, the performance of some of these implant materials that are available sometimes falls short of these goals. The limitations of some of the current materials are the driving purpose for innovative companies like Vallum as they work to develop new surface technology that really enhances osteointegration performance of PEEK.
Q: During the past few years, innovative interbody devices manufactured from PEEK have added porous surfaces, titanium coatings and infusions of hydroxy apatite to improve their performance. What differentiates PEEKplus from those innovations?
EW: Other materials involve surface coatings, macro-porous surfaces, infusions and hydroxyl apatite, which change the actual nature of the PEEK biomaterial itself. While these have some benefit and success, I think ANAB processing to create PEEKplus nanotexturing is a novel approach that has fundamental advantages. ANAB processing does not change the actual nature of the PEEK biomaterial itself and results in four important differentiators:
1. The surface nanotexturing stimulates osteoblastic activity. We think this provides fast and effective boney ongrowth and apposition.
2. Importantly, Vallum's ANAB processing renders the PEEK surface hydrophilic, which also promotes osteoblast proliferation.
3. The process can be applied to any fully manufactured interbody PEEK device without altering its design, size or chemical and mechanical properties.
4. PEEKplus is unlike hybrid interbody PEEK devices because PEEKplus retains all the surface qualities of pure PEEK interbody devices.
PEEKplus is still pure PEEK. The osteointegration is not occurring on a surface treatment, and we haven't changed the PEEK's chemical properties. We changed the surface of the PEEK with nanotexturing. The standard PEEK is hydrophobic and typically never truly osteointegrates. The nanotexturing changes the properties of the PEEK to allow osteoblasts to bind to it because of the nanotexturing and because it's hydrophilic. Those are the big difference.
Q: In your opinion, how important to spinal fusion is the recent FDA clearance for PEEKplus?
EW: While receiving FDA clearance for our PEEK interbody device that incorporates true nanotechnology is a milestone for Vallum, it is also an important demonstration of Vallum's technological leadership in developing advanced nanoprocessing technology. I think the unique abilities of Vallum to produce a nanotextured surface on a PEEK interbody device have the potential to set a new standard for spinal fusion interbody implants. The FDA clearance is the beginning of that process.
I envision many other potential orthopedic applications for Vallum's nanotechnology. The success in this first foray in spine will greatly accelerate in identifying and adapting those applications.
Q: Do you think applying Vallum's surface nanotexturing to other orthopedic devices has the potential to improve their Performance?
EW: If we can improve an implant's osteointegation, then we can potentially reduce other complications of fixation; for example, large implant loosening, or even the spine screw loosening if applied to a pedicle screw. Its simplicity and its ability to be applied to existing manufactured implants, I think, is one of the most attractive aspects of this technology.