The US Food and Drug Administration (FDA) has granted clearance to ZimVie’s spinal fixation system, Vital, for use with BrainLAB’s surgical imaging, planning and navigation tools.
US-based ZimVie and Germany-based Brainlab began working together in March 2023. The two companies partnered to facilitate the integration of the devices into the operating room via Brainlab’s surgery platforms and software.
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Via the partnership, ZimVie developed its Vital and Virage systems to be compatible with Brainlab Spine and Trauma navigation – tools that harness artificial intelligence and mixed reality and are used by surgeons to help plan and carry out spinal procedures and aid robotic assistants and imaging devices.
As part of the agreement, ZimVie will co-market Brainlab’s tools alongside its spinal fixation system products. The Vital sets are expected to have a US launch in early 2024. ZimVie said it also plans to submit a 510(k) application for Virage next year.
Vital and Virage are designed for use in degenerative thoracolumbar procedures. The Vital spinal fixation system includes an optimised instrument and implant kit configuration. With its Brainlab compatibility, surgeons can use navigation technologies during bone preparation and screw placement for precise anatomical localisation.
ZimVie announced a net loss of $5.1m in its Q3 financial results. The company’s third-party spine sales decreased by 9.8%, with ZimVie citing competitive pressures and its exit of business activities in China as factors.
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By GlobalDataZimVie Spine’s global president Rebecca Whitney said: “The strong collaboration between our organisations resulted in an expedited project timeline. We have been focused on expanding our portfolio with enabling technologies to drive greater adoption.”
Alongside expanding its spinal product portfolio, ZimVie recently launched its Azure multi-platform solutions for use in dental laboratory digital workflows in October. The platform consists of 13 prosthetic and restorative digital solutions.
Most recently, Korean company CG Bio received FDA clearance for its Advanced LumFix spinal fixation system.
