There is significant opportunity to innovate in spinal implant surface technology to improve patient outcomes. Vallum Corporation's PEEKplus® nanotexturing for interbody fusion devices recently received FDA clearance and is uniquely differentiated in the spinal device market as it is not a coating, it is not porous, and no chemicals are infused into the PEEK.
This content is sponsored by Vallum.
Instead, Vallum uses its patented Accelerated Neutral Atom Beam technology to create nano-scale concavities between 20 to 50 nanometers in the surface of the PEEK by using a highly controlled acceleration of argon atoms that impact across the existing microsurface to produce the unique nanotexture of PEEKplus.
PEEKplus nanotexturing can be applied to any fully-manufactured PEEK device regardless of design and without altering the chemical or mechanical properties of the original implant.
The company's management believes its advanced technology and processing protocols can ultimately be developed to improve other implantable orthopedic devices for treating disorders throughout the body.
The importance of nanotexturing
A 2006 study published in the Journal of Materials Chemistry examined the efficiency of orthopedic implants with nanotextured surfaces versus conventional materials.1 The study suggested nanophase materials with similar nanometer dimensions as natural bone (<100 nanometers) promote significant new bone formation.
A 2015 study published in the Journal of Biomedical Materials Research investigated the benefits of PEEKplus nanotexturing to promote osteoblast adhesion on PEEK.2 Researchers determined that the nanotexture of PEEKplus significantly increased the cell attachment, metabolic activity and proliferation as compared to untreated PEEK controls (p<0.05).
Listening to spine surgeons
Vallum partnered with SpineUniverse to conduct an implant material and outcomes survey with 100 U.S. surgeons that perform two or more spinal fusions per week with an interbody device. The survey posed various questions to the surgeons about interbody fusion devices and found:
- 78 percent said they use uncoated PEEK interbody devices to perform their fusion procedures, although not exclusively
- 86 percent agreed bone bridging through the center hole of the device is important
- 78 percent indicated four months as an early goal for bone bridging through the center hole of the device
- 91 percent said bony apposition at the endplates is important
- 64 percent consider four months as an early goal for bony apposition at the endplates
When all respondents were asked if they would consider using a new and proprietary PEEK interbody device if it were shown to support early bone bridging and early bony apposition at the end plates, 95 percent said they would be interested.
References
1 Ganesan Balasundaram and Thomas J. Webster. A perspective on nanophase materials for orthopedic implant applications. Journal of Materials Chemistry, Issue 38, 2006.
2 Joseph Khoury et al. Enhanced bioactivity and osseointegration of PEEK with accelerated neural atom beam technology. Journal of Biomedical Materials Research. Nov. 2015.