FDA Approval Granted for Vy Spine's ClariVy OsteoVy PEKK Cervical IBF
Wednesday, November 15, 2023
Vy Spine, a leading innovator in spine technology known for its groundbreaking use of distinctive materials and designs, announced today that it has secured clearance from the U.S. Food and Drug Administration (FDA) for its ClariVy OsteoVy PEKK Cervical Interbody Fusion (IBF) device. This device is designed for single-level intervertebral body fusion in the cervical spine, spanning from C3 to T1, with a focus on treating degenerative disc disease (DDD).
The ClariVy OsteoVy PEKK Cervical IBF stands out by combining the unique OXPEKK material's osseointegration properties with Vy Spine's proprietary OsteoVy lattice structure. Notably, PEKK implants, unlike their PEEK counterparts, exhibit bone ingrowth, do not cause radiographic interference, prevent fibrotic tissue membrane formation, show a significant increase in bony apposition over time, and possess substantially higher push-out strength compared to standard PEEK.Vy Spine's exclusive OsteoVy lattice structure plays a pivotal role in facilitating bony integration and wicking, leveraging the hydrophilic nature of PEKK as a material to provide enhanced benefits as an interbody implant.
These future implants are anticipated to capitalize on the distinctive qualities inherent in the proprietary OsteoVy PEKK designs. This underscores Vy Spine's dedication to advancing spine care through cutting-edge materials and designs, aiming to optimize intervertebral body fusion devices for effectively addressing degenerative disc disease within the cervical spine.