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Spine companies continue to focus on surface treatments and new manufacturing processes to support more solid fusions. This was evidenced by new product launches and symposiums on these topics at the 2015 North American Spine Society Annual Meeting.
One scientific symposium was devoted to discussion of the best material for a structural interbody device. Cases were argued for PEEK, bone, ceramic and titanium, and all highlighted the need to improve PEEK’s performance. Similar conversations played out in the exhibit hall, with the introduction of more than half a dozen PEEK spacers coated in titanium to improve the bone/implant interface. The use of surface technologies is expected to evolve in the interbody segment. PEEK has maintained its popularity due to its chemical and wear resistance, as well as its radiolucency. However, some surgeons and industry players have questioned the long-term impact of metal-coated plastic.
Startup Vertera Spine announced a new perspective on PEEK with its FDA 510(k) clearance for COHERE™, reportedly the first FDA-cleared spine device to be manufactured entirely out of PEEK and contain porosity. Contrasted to a surface treatment, the Scoria™ biomaterial is grown directly out of solid PEEK material (in this instance, Solvay’s Zeniva®) to create a seamless surface-to-solid material interface that the company reports is more durable than a coating.
“We have the same benefits as PEEK in terms of the chemical properties that mimic bone and the ability to be able to x-ray the fusion, but the one added and dynamic feature is that we make the actual PEEK material osteoconductive,” says Chris Lee, Ph.D., co-founder and CEO of Vertera Spine. “The porosity has an external roughness that elicits bony tissue ingrowth. That’s a big advantage, as everyone is trying to move to metal coatings or HA impregnated materials to elicit that more osteoconductive response. We’re actually able to make the PEEK inherently osteoconductive without adding to it.”
Vertera’s recent FDA clearance addresses a cervical cage; the company has plans for a lumbar design.
Additionally, the use of additive manufacturing has grown in the interbody space, as companies seek to develop unique structures with greater porosity. K2M introduced Lamellar Titanium Technology™ for initial use on CASCADIA™ systems; 4WEB Medical launched the Posterior Spine Truss system; joimax launched EndoLIF® On-Cage, made of a 3D-printed titanium alloy and Nexxt Spine announced development of NanoMatrixx, a 3D-printed porous bioactive titanium material. These systems join Oxford Performance Materials’ SpineFab® VBR, which received 510(k) clearance in July 2015.
