RA’ANANA, Israel--(BUSINESS WIRE)--VUZE Medical, a privately-held company aiming to transform intra-operative guidance in minimally invasive spinal interventions, has successfully concluded a 20-patient clinical study for its VUZE System evaluating safety, accuracy and user experience at the Rambam Healthcare Campus, a 1,000-bed academic hospital in Haifa, Israel. The scope of the study was short-segment stabilizations in the thoracolumbar spine including fixations, fixations coupled with fusions, and augmentations. The VUZE System previously received U.S. FDA 510(k) clearance in early 2022 and the company has received seven related patents so far in the U.S., Europe and Asia.
The VUZE System is a software solution installed on an off-the-shelf PC. It uses no markers, references or cameras and requires no 3D imaging in the operating room (OR). Using proprietary image processing, it overlays in real time graphical representations of standard unmodified 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 scan.
The study’s investigators compared the views displayed by VUZE for all pedicle screws and over 90 percent of needles with actual post-insertion 3D verification scans. All comparisons demonstrated high accuracy without exception and received the highest possible evaluation score from the investigators. Additionally, user experience was graded as very satisfactory, no device deficiencies were observed, and no device-related adverse events were reported.
“VUZE is a game changer,” said Ory Keynan, MD, head of the spine unit at Rambam and the study’s principal investigator. “It gives us consistently high accuracy together with the simplicity and ease of use of standard X-ray guidance, avoiding the complexity of cumbersome navigation systems. All we need in the OR is a 2D C-Arm and a PC running the VUZE software and we are free to choose our preferred surgical tools. We expect to be using VUZE more and more.”
A convenient combination of 2D imaging during surgery and the in-OR 3D verification scans, all using the same C-Arm, was provided by a Cios Spin from Siemens Healthineers. (For regular use of the VUZE system, only 2D X-ray is required and there is no need for in-OR 3D imaging.)
“The completion of this clinical trial is a positive step towards bringing VUZE to surgical centers where it can provide effective guidance during common spine surgeries with an easy-to-use technology,” said David Tolkowsky, founder and CEO of VUZE Medical. “Our solution fits into commonly-equipped operating rooms and within the existing surgical workflows. Additionally, we foresee a broad range of further skeletal interventions to follow.”
Over three million surgeries for correcting spinal instability and/or deformation, collectively known as spinal stabilizations, are performed annually worldwide, with a third of those in the U.S.1 These procedures include vertebral fixation with pedicle screws, vertebral fixation coupled with fusion, and vertebral augmentation with synthetic or biological cement. Approximately 80 percent of stabilizations treat short spinal segments.1 Short-segment surgeries are most often performed manually and are typically assisted only by standard 2D X-ray.
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 spinal interventions currently aided only by standard 2D X-Ray. The company’s VUZE System is a unique software-based solution that instantly merges intra-operative X-ray with pre-operative CT, providing surgeons with the cross-sectional images they need most during surgery and currently lack. The system is targeted primarily at outpatient and ambulatory settings. For more information, visit www.vuzemedical.com.
1. Orthopedic Network News: 2020 Spinal Surgery Update
