FDA clears Vertera Spine porous surface fusion device

Vertera Spine recently announced it received FDA 510(k) clearance for its COHERE Cervical Interbody Fusion Device, which is the first FDA-cleared spine device to be manufactured entirely of PEEK and contain porosity.

The new cervical fusion device features Vertera Spine’s PEEK Scoria biomaterial, which is a proprietary porous surface technology, according to a press release.

“The FDA clearance of COHERE represents a significant milestone for Vertera Spine and fusion devices in spine,” Chris Lee, PhD, co-founder and CEO of Vertera Spine, stated in the release. “Given the new economics of health care, 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.”

The PEEK Scoria biomaterial was developed to address the clinical need for fusion devices that better osseointegrate while still remaining cost-effective. Unlike other devices that with surface treatment coatings directly on them, the Scoria material is grown out of the solid PEEK Zeniva material, which creates a seamless surface-to-solid material interface, according to the release.

Vertera Spine and Solvay will exhibit COHERE and PEEK Scoria at Booth #1483 at the North American Spine Society Annual Meeting on Oct. 14-17, in Chicago.

Reference: www.verteraspine.com