VUZE Medical Showcases Multi-Tool 3D Guidance in Spine Surgery

VUZE Medical has demonstrated concurrent software-based 3D guidance of dual-sided vertebral insertions. The new Tandem mode—not yet approved for clinical use—was used in cadaveric surgery before a live audience of 150 professionals at the North American Spine Society 2024 Annual Meeting, the company announced today. Tandem mode is an intended future addition to the company’s software-based, U.S. Food and Drug Administration (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) 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 received 12 related patents in the United States, 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, M.D., VUZE consultant and orthopedic spine surgeon who practiced for 28 years in the San Francisco Bay area. “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.”

More than 3 million¹ surgeries for correcting spinal instability and/or deformation (spinal stabilizations) are performed worldwide annually, with as many as one-third of those¹ in the United States. 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 are designed to treat short spinal segments.¹ Standard 2D X-ray is most often employed in short-segment surgeries. Pedicle screw misplacement risk, however is higher under X-ray guidance than in navigated surgery.^2,3

“Our newly-demonstrated Tandem mode is as far as we are aware a world first,” VUZE Medical Founder/CEO David Tolkowsky said. “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.”

VUZE Medical is a privately-held medical technology company striving 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 computed tomography 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.

References
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