VySpine gets FDA clearance for new cervical fusion device

Spinal Tech

VySpine earned FDA clearance for its ClariVy OsteoVy PEKK device for one-level cervical interbody fusion, the company said in a Nov. 14 news release. 

The device combines the osseointegration properties of the OXPEKK material and VySpine's OsteoVy lattice structure. It is indicated for treating degenerative disc disease.

PEKK implants don't have any radiographic interference, no fibrotic tissue membrane formation and show increased bony apposition and higher push-out strength compared to PEEK implants.

"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," Brett Berry, president of product development at VySpine, said in the release. "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."

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