Bountiful, UT – October 9, 2024 /OrthoSpineNews/ — Vy Backbone, a spine innovation chief utilizing differentiated supplies and designs, introduced at this time that it has acquired U.S. Food and Drug Administration (FDA) clearance for its LumiVy OsteoVy PEKK Lumbar IBF.
The system is indicated for intervertebral physique fusion to be used at both one stage or two contiguous ranges within the lumbar spine, from L2 to S1, for the therapy of degenerative disc illness (DDD) with as much as Grade 1 spondylolisthesis. The LumiVy OsteoVy PEKK Lumbar IBF 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 spread of lordosis, and hyperlordosis. The LumiVy Lumbar IBF System additionally options IBF-S implants, which have self-drilling screws to assist in anchoring the system 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 energy in comparison with normal PEEK. Along with these product advantages, OXPEKK is bacterostatic and an excellent choice for sufferers with metallic hypersensitivity. Vy Backbone’s proprietary OsteoVy lattice construction aids in bony integration in addition to wicking, PEKK being a hydrophilic materials, to supply even better 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,” mentioned Bret Berry, President of Product Growth for Vy Backbone. “As we researched OXPEKK and its distinctive traits, we discovered that this composition accomplishes what PEEK can’t. We’re excited concerning the OXPEKK materials and our continued partnership with Oxford Efficiency Supplies.”
“We’re thrilled that Vy Backbone has reached this vital milestone with its second OsteoFab product approval,” mentioned 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 throughout the spine market will drive substantial adoption of this best-in-class resolution.”
About Vy Backbone, LLC.
VySpine was created by way of energetic inner improvement and the licensing of varied confirmed applied sciences utilizing revolutionary supplies and designs. The corporate strives to outpace the competitors by collaborating with key spine innovators whereas offering a versatile, cost-effective method to spine care. Be taught extra at www.vyspine.com
About Oxford Efficiency Supplies, Inc.
Based in 2000, Oxford Efficiency Supplies (OPM) is a pioneer within the improvement and commercialization of superior supplies and additive manufacturing applied sciences. OPM’s proprietary OsteoFab know-how leverages the high-performance PEKK (poly-ether-ketone-ketone) polymer and state-of-the-art 3D printing expertise to provide gadgets that handle essential challenges in at this time’s orthopedic business. OPM gives the world’s solely implantable medical gadgets which are personalised, metal-free, osseointegrative, anti-bacterial, radiolucent, and totally modifiable within the working room. OPM is in business manufacturing of quite a few orthopedic implant purposes, together with decrease & higher extremity, oncology, trauma, cranial, facial, spinal, and sports activities drugs gadgets. OPM has additionally developed patented PEKK nanocoating applied sciences to enhance efficiency of metallic implants.
“Vy Backbone,” “LumiVy,” and “OsteoVy,” are registered logos of Vy Backbone.
“OsteoFab,” “OXFAB” and “OXPEKK” are registered logos of Oxford Efficiency Supplies.
Media Contact: Paul Williams, 310-569-0023, paul@medialinecommunications.com
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