Sam Brusco, Associate Editor03.08.22
Spinal technology maker VySpine has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its LumiVy Lumbar IBF system for use after lumbar discectomy in fusion procedures.
The system touts lumbar interbody fusion implants made from either PEEK (polyether ether ketone) Optima LT1 or PEEK Optima HA (hydroxyapatite)-Enhanced. PEEK Optima has been the standard for interbodies for decades, and PEEK Optima HA-Enhanced contains embedded HA fibers for better bony apposition.
“The LumiVy Lumbar IBF System is our latest innovation in a series of comprehensive interbody systems being developed by VySpine,” Tom McLeer, CEO of VySpine told the press. “The LumiVy system addresses all lumbar approaches while offering the broadest range of differentiated materials for optimal bony integration. Using new materials and surgeon input, we are building exceptional quality, flexibility, and pricing into all our products.”
The system comes in various footprints and heights and addresses approaches including anterior, oblique anterior, lateral, oblique posterior, posterior, and transforaminal. The implants are also available in a wide range of lordosis. The IBF-S implants have self-drilling screws to help anchor the device to bone.
The system touts lumbar interbody fusion implants made from either PEEK (polyether ether ketone) Optima LT1 or PEEK Optima HA (hydroxyapatite)-Enhanced. PEEK Optima has been the standard for interbodies for decades, and PEEK Optima HA-Enhanced contains embedded HA fibers for better bony apposition.
“The LumiVy Lumbar IBF System is our latest innovation in a series of comprehensive interbody systems being developed by VySpine,” Tom McLeer, CEO of VySpine told the press. “The LumiVy system addresses all lumbar approaches while offering the broadest range of differentiated materials for optimal bony integration. Using new materials and surgeon input, we are building exceptional quality, flexibility, and pricing into all our products.”
The system comes in various footprints and heights and addresses approaches including anterior, oblique anterior, lateral, oblique posterior, posterior, and transforaminal. The implants are also available in a wide range of lordosis. The IBF-S implants have self-drilling screws to help anchor the device to bone.