Pentamed® - High performance packaging films for medical devices

FDA Grants Breakthrough Clearance to Vy Spine's Revolutionary ClariVy OsteoVy PEKK Cervical IBF

Vy Spine, at the forefront of spinal innovation renowned for its distinctive materials and designs, has recently revealed the successful clearance granted by the U.S. Food and Drug Administration (FDA) for its groundbreaking ClariVy OsteoVy PEKK Cervical IBF. Specifically designed for intervertebral body fusion in the cervical spine, spanning from C3 to T1, this device is customized to address degenerative disc disease (DDD) at a single level.

The ClariVy OsteoVy PEKK Cervical IBF distinguishes itself by integrating the exceptional osseointegration features of the OXPEKK material with the exclusive OsteoVy lattice structure. Noteworthy is the distinctiveness of PEKK from PEEK, exhibiting bone ingrowth, minimal radiographic interference, prevention of fibrotic tissue membrane formation, a substantial increase in bony apposition over time, and notably higher push-out strength compared to standard PEEK.

The OsteoVy lattice structure plays a pivotal role in promoting bony integration and wicking, maximizing the benefits of PEKK's hydrophilic nature. This combined approach positions the ClariVy OsteoVy PEKK as an exceptional interbody implant with enhanced advantages. The FDA clearance serves as the inaugural milestone among a succession of Vy Spine implants strategically harnessing the distinctive attributes of their proprietary OsteoVy PEKK designs.


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