Medical devices developer Vertera Spine has received 510(k) approval from the US Food and Drug Administration (FDA) for its Cohere cervical interbody fusion device.
The device features the firm’s new Peek Scoria biomaterial, a proprietary porous surface technology that is based on Zeniva Peek resin from Solvay Specialty Polymers.
Cohere interbody fusion device is said to leverage Peek Scoria to aggregate the benefits of introducing a porous environment to bone without compromising the mechanical integrity of the implant.
The device will also not produce any medical imaging artifacts, helping the surgeon to easily assess the fusion site.
The firm will introduce Cohere in multiple footprint and height configurations in 2016.
Vertera Spine co-founder and CEO Dr Chris Lee said: "The FDA clearance of Cohere represents a significant milestone for Vertera Spine and fusion devices in spine.
"Given the new economics of healthcare, market demands are shifting towards more effective implant technologies at a better price."
The cost-effective Peek Scoria was developed to meet the clinical need of fusion devices, allowing to improve osseointegrate and to facilitate bone tissue in-growth.
Peek Scoria features a fully interconnected pore network with 300um average pore size, over 500µm layer thickness, and wettable surface.
Vertera Spine and Solvay will exhibit Cohere and Peek Scoria at the North American Spine Society meeting in Chicago, which will be held from 14 to 17 October.
Vertera Spine has secured grant funding from the National Science Foundation and Georgia Research Alliance to transform its growing technology portfolio into commercial products.
Image: Vertera Spine’s Cohere cervical interbody fusion device. Photo: courtesy of PRNewswire/Vertera Spine.