RA’ANANA, Israel – Nov. 25, 2024 – VUZE Medical, a privately-held company aiming to transform intra-operative guidance in spinal interventions currently aided only by 2D X-ray, has recently demonstrated concurrent software-based 3D guidance of dual-sided vertebral insertions. The new Tandem mode, which is not yet approved for clinical use, was recently introduced in cadaveric surgery before a live audience of 150 professionals at the 2024 annual meeting of the North American Spine Society. Tandem mode is an intended future addition to the company’s software-based, FDA-cleared VUZE System.
The VUZE System is a software solution installed on an off-the-shelf PC. It operates with unmodified surgical tools, uses no markers, references or cameras, and makes 3D imaging in the operating room (OR) entirely optional. Using proprietary image processing algorithms, it overlays in real time graphical representations of standard surgical tools seen in intra-operative 2D X-ray images onto axial and sagittal cross-sections that it generates from the patient’s standard pre-operative CT (or in-OR 3D) scan. VUZE has already received twelve related patents in the U.S., Europe, China and India, including tie-ins with robotics, augmented reality (AR) and traditional hardware-based navigation.
“I believe the new Tandem mode has the potential for further reducing time and radiation during spinal interventions assisted by VUZE,” said Paul Slosar, MD, an orthopedic spine surgeon who practiced for 28 years in the San Francisco Bay area and consultant for VUZE. “Not only that, as in the FDA-cleared single-tool mode, no lateral X-ray images are needed at all, the same anterior-posterior images can now be used for simultaneously guiding left-and right-sided vertebral insertions performed by two surgeons working in parallel.”
“Our newly-demonstrated Tandem mode is as far as we are aware a world first,” said David Tolkowsky, founder and CEO of VUZE Medical. “It is raising strong interest among surgeons due to the significant potential for a much-improved surgical workflow, a potential that will be further validated and quantified.”
Over three million1 surgeries for correcting spinal instability and/or deformation, collectively known as spinal stabilizations, are performed annually worldwide, with as many as a third of those1 in the U.S. These procedures include vertebral fixation with pedicle screws, vertebral fixation coupled with fusion, and vertebral augmentation with synthetic or biological cement. The vast majority of stabilizations treat short spinal segments1. Short-segment surgeries are most often assisted only by standard 2D X-ray. The risk of pedicle screw misplacement has been shown to be greater under X-ray guidance than in navigated surgery 2,3.
About VUZE Medical
VUZE Medical is a privately-held medical technology company that aims to provide highly accurate and cost-effective surgical guidance for common skeletal interventions currently aided only by standard 2D X-Ray, with a current focus on spine. The company’s VUZE System is a unique software-based solution that instantly merges intra-operative X-ray with pre-operative CT or CBCT, providing surgeons with the cross-sectional images they need most during surgery and traditionally lack. The system is targeted primarily at outpatient and ambulatory settings. For more information, visit www.vuzemedical.com.
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Joe Duraes
Pazanga Health Communications
917-687-6419
1. Orthopedic Network News: 2020 & 2023 Spinal Surgery Updates
2. “Computer-Assisted Navigation Is Associated with Decreased Rates of Hardware-Related Revision After Instrumented Posterior Lumbar Fusion,” Bovonratwet et al., Global Spine Journal, May 2023
3. “Comparison of major spine navigation platforms based on key performance metrics: a meta-analysis of 16,040 screws,” Bonello et al., European Spine Journal, Sep 2023