BOUNTIFUL, Utah–(BUSINESS WIRE)–Vy Spine, a spine innovation leader using differentiated materials and designs, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VyBrate VBR System which is designed for use in both the cervical and thoracolumbar spine for vertebral body replacement surgery.
The VyBrate VBR is an innovative device combining the osseointegration properties of the OXPEKK material and the novel OsteoVy lattice structure unique to Vy Spine. Additionally, the VyBrate VBR device is the first vertebral body replacement device on the market made using OsteoVy PEKK, developed in partnership with Oxford Performance Materials.
Unlike standard PEEK implants, PEKK implants have demonstrated bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, significant increase in bony apposition over time, and significantly higher push-out strength compared to PEEK.
Vy Spine’s proprietary OsteoVy lattice structure aids in bony integration as well as wicking –because PEKK is a hydrophilic material – to provide greater benefit as an interbody implant.
“This VyBrate VBR clearance is the latest in a long line of approvals for Vy Spine implants which utilize the unique qualities of our proprietary OsteoVy PEKK designs,” said Bret Berry, President of Product Development at Vy Spine. “As we continue to research OXPEKK and its unique characteristics, we have demonstrated that this unique composition accomplishes what we as an industry had always hoped PEEK would accomplish, but PEEK fell short. We are very excited about the OXPEKK material and our continued partnership with Oxford Performance Materials.”
About Vy Spine
Vy Spine was created through active internal development and the licensing of various proven technologies using innovative materials and designs. This comprehensive line of core spine products and newly developed specialty products allow us to meet the needs of both health care providers and surgeons. The company strives to outpace the competition by collaborating with key spine innovators while providing a flexible, cost-effective approach to spine care. Learn more at www.vyspine.com.
About Oxford Performance Materials, Inc.
Oxford Performance Materials, Inc. was founded in 2000 to exploit and commercialize the world’s highest performing thermoplastic, PEKK (poly-ether-ketone-ketone). OPM’s Materials business has developed a range of proprietary, patented technologies for the synthesis and modification of a range of PAEK polymers that are sold under its OXPEKK brand, including coating technologies for a range of industrial and biomedical applications. The Company is a pioneer in 3D printing. OPM’s OsteoFab technology is in commercial production in numerous orthopedic implant applications, including cranial, facial, spinal, and sports medicine devices, and OPM’s OXFAB production parts are designed for highly demanding industrial applications.
“Vy Spine” “VyBrate” and “OsteoVy PEKK” are registered trademarks of Vy Spine.
“OXPEKK” “OXFAB” and “OsteoFab” are registered trademarks of Oxford Performance Materials.
Contacts
Media Contact: Paul Williams, 310-569-0023, [email protected].
