Device company Vertera Spine, a specialist in advanced functional surface technologies for spine applications, tells us it has received U.S. FDA 510(k) clearance for its COHERE™ Cervical Interbody Fusion Device.
Background
PEEK implants with porous or rough metal coatings are not a new phenomenon in clinical applications, especially in the spine. Vertera’s COHERE is however the first FDA cleared spine device to be manufactured entirely out of a porous PEEK.
COHERE features Vertera Spine’s novel PEEK Scoria™ biomaterial, a proprietary porous surface technology that is based on Zeniva® PEEK resin from a company called Solvay Specialty Polymers.
Unlike surface treatments that are coated onto the device, Scoria is grown directly out of the solid PEEK Zeniva material, creating a seamless surface-to-solid material interface that is more durable than metal coatings and much 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 innovative 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.
Vertera Spine will be showcasing its COHERE system at the forthcoming NASS congress (Chicago Oct 14-17) and launching it in multiple footprint and height configurations in 2016.
Company comments
“The FDA clearance of COHERE represents a significant milestone for Vertera Spine and fusion devices in spine,” said Chris Lee, PhD, 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 with over 20 years experience in the spine and orthopedics industries. “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.”
Source: Vertera Spine, Inc.
published: October 9, 2015 in: Approval/Clearance, Congresses and Meetings, Spine