Vertera Spine Earns Clearance for Cervical Interbody Fusion Device

Atlanta, Ga.-based Vertera Spine (Vertera Inc.), which makes devices with advanced surface technology for spine applications, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Cohere cervical interbody fusion device.

Cohere features Vertera Spine’s PEEK (polyether ether ketone) Scoria biomaterial, a proprietary porous surface technology that is based on Zeniva PEEK resin from Solvay Specialty Polymers Inc. While PEEK implants with porous or rough metal coatings have found their way into clinical use, Cohere is the first FDA cleared spine device to be manufactured entirely out of PEEK and contain porosity.

PEEK Scoria was developed to address the clinical need for fusion devices that better osseointegrate while still remaining cost-effective. Backed by extensive research at Duke University and the Parker H. Petit Institute for Bioengineering and Bioscience at Georgia Institute of Technology, Scoria represents a breakthrough in how surface technologies are applied to medical devices. Unlike surface treatments that are coated onto the device, Scoria is grown directly out of the solid PEEK Zeniva material, creating what is touted to be seamless surface-to-solid material interface that is more durable than metal coatings and two times stronger under shear loading than trabecular bone.

In addition, because Scoria can be fabricated onto the device without using any additive material, manufacturing costs are significantly lowered compared with metal-coated implants. This process allows implants with this porous technology to be priced competitively with current PEEK device offerings and more cost effective than titanium-coated fusion devices.

“The FDA clearance of Cohere represents a significant milestone for Vertera Spine and fusion devices in spine,” said Chris Lee, Ph.D., co-founder and CEO of Vertera Spine. “Given the new economics of healthcare, market demands are shifting towards more effective implant technologies at a better price. Cohere, featuring surface porous PEEK Scoria, will be the first in a new generation of biomedical implant innovations to meet this demand.”

“Surgeons have been seeking an all PEEK fusion solution that leads to direct bone apposition instead of fibrous encapsulation,” said Tim Nash, Vertera Spine board director. “Cohere is a game-changing device for spine fusion.  By leveraging the performance of the Scoria technology, Vertera Spine will be able to generate a portfolio of implant solutions that were previously not possible.”