Vy Spine Announces FDA Approval for its ClariVy OsteoVy PEKK Cervical IBF
Tallahassee, Florida, November 14, 2023 – OrthoSpineNews – Vy Spine, a leader in spine innovation using differentiated materials and designs, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) 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 new ClariVy OsteoVy PEKK Cervical IBF device combines the osseointegration properties of the OXPEKK material and the OsteoVy lattice structure unique to Vy Spine. PEKK implants (as opposed to PEEK) implants exhibit bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, a significant increase in bony apposition over time, and a significantly higher push-out force compared to standard PEEK.
Vy Spine’s patented OsteoVy lattice structure helps with bone integration and fluid drainage, because PEKK is a hydrophilic material, to provide even more benefits as an interbody implant.
“The ClariVy OsteoVy PEKK approval is the first in a long line of Vy Spine implants that will leverage 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 achieves what we as an industry had always hoped PEEK would achieve. But PEEK fell short. We are very excited about the OXPEKK material and our collaboration with Oxford Performance Materials to make this new device possible.”
“We are thrilled that Vy Spine has achieved this important milestone,” said Scott DeFelice, CEO of Oxford Performance Materials. “We are confident that the combination of OPM’s new, 3D printed OsteoFab technology and Vy Spine’s innovative designs and experience in the spine market will drive substantial adoption of this best-in-class solution.”
About Vy Spine, LLC.
VySpine was created through active internal development and licensing of several proven technologies using innovative materials and designs. The company strives to outperform its competitors by partnering with key spine innovators while providing a flexible, cost-effective approach to spine care. More information can be found at www.vyspine.com.
About Oxford Performance Materials, Inc.
Oxford Performance Materials, Inc. was founded in 2000 to exploit and market the world’s highest performing thermoplastic plastic, PEKK (polyether-ketone-ketone). OPM’s Materials division has developed a range of proprietary technologies for the synthesis and modification of a range of PAEK polymers sold under the OXPEKK® brand, including coating technologies for a range of industrial and biomedical applications. The company is a pioneer in the field of 3D printing. OPM’s OsteoFab® technology is commercially produced 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.
Media contact: Paul Williams, 310-569-0023, paul@medialinecommunications.com
