10 Mar VySpine Announces FDA Clearance for LumiVy Lumbar IBF System
TALLAHASSEE, Fla.–(BUSINESS WIRE)–VySpine, a spine innovation leader using differentiated materials and designs, announced today that it has received 510(k) clearance from the FDA for its LumiVy Lumbar IBF System which is designed for use after lumbar discectomy in fusion procedures.
The LumiVy Lumbar IBF System features lumbar interbody fusion devices made from either PEEK Optima LT1 or PEEK Optima HA-Enhanced. PEEK Optima LT1 has been the standard for interbody devices for decades due to its radiolucency and a modulus of elasticity close to that of natural bone. PEEK Optima HA-Enhanced has embedded Hydroxyapatite fibers to create better bony apposition to the implant.
“The LumiVy Lumbar IBF System is our latest innovation in a series of comprehensive interbody systems being developed by VySpine,” said Tom McLeer, CEO of VySpine. “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 LumiVy Lumbar IBF System is offered in numerous footprints and heights, and addresses a full range of lumbar interbody approaches including anterior, oblique anterior, lateral, oblique posterior, posterior, and transforaminal. Additionally, the LumiVy implants are available in a wide range of lordosis. The LumiVy Lumbar IBF System also features IBF-S implants, which have self-drilling screws to aid in anchoring the device directly to the bone.
VySpine was created through active internal development and the licensing of various proven technologies using innovative materials and designs. This comprehensive line of core spine products and newly developed specialty products allow us to meet the needs of both health care providers and surgeons. The company strives to outpace the competition by collaborating with key spine innovators while providing a flexible, cost-effective approach to spine care. Learn more at vyspine.com
“VySpine” and “LumiVy” are registered trademarks of VySpine.
“PEEK Optima” is a registered trademark of Invibio Biomaterial Solutions.
Paul Williams, 310-569-0023, firstname.lastname@example.org.
SOURCE: Business Wire, March 8 2022