Vy Backbone has obtained FDA clearance for its 3D printed LumiVy OsteoVy PEKK Lumbar IBF machine.
The machine is indicated for intervertebral physique fusion to be used at both one stage or two contiguous ranges within the lumbar backbone, from L2 to S1, for the remedy of degenerative disc illness (DDD) with as much as Grade 1 spondylolisthesis. It combines the osseointegration properties of the 3D printed OXPEKK materials and the novel OsteoVy lattice construction distinctive to Vy Backbone.
The LumiVy OsteoVy PEKK Lumbar IBF is obtainable in quite a few footprints and heights, starting from 6mm to 21mm addressing a full vary of lumbar interbody approaches together with anterior, indirect anterior, lateral, indirect posterior, posterior, and transforaminal. Moreover, the LumiVy OsteoVy PEKK Lumbar IBF implants can be found in a variety of lordosis, and hyperlordosis. The LumiVy Lumbar IBF System additionally options IBF-S implants, which have self-drilling screws to help in anchoring the machine on to the bone.
OXPEKK has demonstrated bone ingrowth, no radiographic interference, no fibrotic tissue membrane formation, a major enhance in bony apposition over time, and considerably greater push-out power in comparison with normal PEEK. Along with these product advantages, OXPEKK is bacterostatic and a super possibility for sufferers with metallic hypersensitivity. Vy Backbone’s proprietary OsteoVy lattice construction is claimed to help in bony integration in addition to wicking, PEKK being a hydrophilic materials, to supply even larger profit as an interbody implant.
“The LumiVy OsteoVy PEKK Lumbar IBF clearance is one other product in a protracted line of Vy Backbone implants which is able to make the most of the distinctive qualities of our proprietary OsteoVy PEKK designs,” stated Bret Berry, President of Product Improvement for Vy Backbone. “As we researched OXPEKK and its distinctive traits, we discovered that this composition accomplishes what PEEK can not. We’re excited concerning the OXPEKK materials and our continued partnership with Oxford Efficiency Supplies.”
“We’re thrilled that Vy Backbone has reached this necessary milestone with its second OsteoFab product approval,” added Scott DeFelice, CEO of Oxford Efficiency Supplies. “We’re assured that the mix of OPM’s novel 3D printed PEKK know-how and Vy Backbone’s distinctive designs & expertise inside the backbone market will drive substantial adoption of this best-in-class resolution.”
