![]() ![]() "The FDA clearance of COHERE represents a significant milestone for Vertera Spine and fusion devices in spine, " said Dr. The company believes that this type of PEEK implant surface is more durable than metal coatings and two times stronger under shear loading than trabecular bone.īecause PEEK Scoria can be fabricated onto the device without using any additive material, manufacturing costs are lower than metal-coated implants which should result in more competitive pricing as compared with more traditional coated PEEK implants or even titanium-coated fusion devices. As a result, the implant has a seamless surface-to-solid material interface. Unlike other PEEK surface treatments that are coated onto the device, Scoria is grown directly out of the solid PEEK Zeniva material. Petit Institute for Bioengineering and Bioscience at Georgia Institute of Technology. The PEEK Scoria technology came from research conducted at Duke University and the Parker H. ![]() The underlying technology for COHERE, PEEK Scoria, “represents a breakthrough in how surface technologies are applied to medical devices, ” according to Dr. In the end, we believe we have developed an elegant, more cost-effective solution with superior mechanical and biological performance that can also be advantageous for implants outside of spine.” “We took a fundamentally different approach by growing a porous PEEK network directly from COHERE's surface, thus maintaining PEEK's advantageous mechanical properties, while also allowing bone to mechanically interlock directly within the porosity without eliciting fibrous encapsulation. These offerings have several inherent problems related to their mechanical durability and cost associated with added material.” Numerous companies have tried to make PEEK more osteoconductive by adding materials like titanium to the implant surface or hydroxyapatite to the bulk material. But COHERE is the first FDA cleared spinal implant manufactured entirely out of PEEK which also is porous.Ĭo-founder and CEO of Vertera Spine Chris Lee, Ph.D., told OTW, "Our primary development objective for COHERE was to address the biologic challenges associated with current PEEK devices while keeping manufacturing costs low. Several PEEK implants with porous or rough metal coatings are in use today. The implant’s proprietary surface technology is porous and is based on Zeniva PEEK resin from Solvay Specialty Polymers. Food and Drug Administration 510(k) clearance for a uniquely osteoconductive and porous PEEK Cervical Interbody Fusion Device called simply COHERE.
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