N2 Biomedical has announced that the first polyetheretherketone (PEEK) interbody fusion device coated with its titanium coating technology was successfully implanted in a patient. This coating forms part of the company’s NanoTitanium family of coatings.
According to N2 Biomedical, the titanium coating is less than a micrometre thick and is deposited using an advanced vacuum coating technology known as Ion Beam Assisted Deposition (IBAD), a process which combines evaporation with concurrent ion bombardment to provide coating adhesion and control over properties such as surface morphology and coating density.
A company press release states that PEEK is frequently used to fabricate orthopaedic and spinal devices, in part due to its chemical inertness, radiolucency, and an elastic modulus that is closely matched to natural bone. However, PEEK surfaces provide relatively poor bone tissue attachment compared to titanium-based devices, which can reduce the probability of a successful fusion.
N2 Biomedical claim numerous scientific studies have shown that titanium coatings on PEEK can promote and increase new bone growth and result in stronger bone attachment, however, recent studies have also shown that the thicker thermal plasma spray (TPS) titanium coatings commonly used on PEEK implants can liberate titanium particles upon impaction, leading to complications such as phagocytosis.
The company reports that to overcome the drawbacks of thick porous titanium coatings, there is growing interest in very thin (about one micron or less) titanium coatings on PEEK-based devices deposited using atomic-level deposition techniques such as IBAD, rather than through bonding or agglomeration of large titanium particles at high temperature. N2 Biomedical claims its titanium coating provides these advantages while passing all of the requisite standardised mechanical adhesion and durability tests.
Eric Tobin, CEO of N2 Biomedical (Bedford, USA), states: “We are very excited to see our titanium coating utilised for the first time in a clinical application. This is the culmination of a significant effort made by numerous individuals both at N2 and the device manufacturer. PEEK spinal interbody devices are an ideal application for this coating, and its clinical utilisation supports N2’s core mission of enhancing performance of our customers’ devices with advanced technology. Our coatings have a wide array of uses in orthopaedic and spinal devices, and we look forward to further expanding application of these coatings in a range of surgical procedures.”