TALLAHASSEE, Fla.--(BUSINESS WIRE)--Vy Spine, a spine innovation leader using differentiated materials and designs, announced today that it has received U.S. Food and Drug Administration (FDA) clearance for its ClariVy OsteoVy PEKK Cervical IBF, indicated for intervertebral body fusion for use at one level in the cervical spine, from C3 to T1, for the treatment of degenerative disc disease (DDD).
The novel ClariVy OsteoVy PEKK Cervical IBF device combines the osseointegration properties of the OXPEKK material and the OsteoVy lattice structure unique to Vy Spine. PEKK (unlike PEEK) implants demonstrate 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 standard PEEK.
Vy Spine’s proprietary OsteoVy lattice structure aids in bony integration as well as wicking, PEKK being a hydrophilic material, to provide even greater benefit as an interbody implant.
“The ClariVy OsteoVy PEKK clearance is the first in a long line of Vy Spine implants which will utilize the unique qualities of our proprietary OsteoVy PEKK designs,” said Bret Berry, President of Product Development for Vy Spine. “As we researched OXPEKK and its unique characteristics, we began to realize that its 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 partnership with Oxford Performance Materials to make this new device possible.”
“We are thrilled that Vy Spine has reached this important milestone,” said Scott DeFelice, CEO of Oxford Performance Materials. “We are confident that the combination of OPM’s novel, 3D printed OsteoFab technology and Vy Spine’s innovative designs and experience within the spine marketplace will drive substantial adoption of this best-in-class solution.”
About Vy Spine, LLC.
Vy Spine was created through active internal development and the licensing of various proven technologies using innovative materials and designs. 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,” “ClaiVy,” and “OsteoVy,” are registered trademarks of Vy Spine.