VUZE 2.0 designed to supply prolonged performance, broader inter-operability whereas nonetheless requiring no software modifications, cameras, markers or references
RA’ANANA, Israel, October 10, 2023–(BUSINESS WIRE)–VUZE Medical, a privately-held firm aiming to rework intra-operative steering in minimally invasive spinal interventions, has submitted a 510(okay) submitting with the U.S. Food and Drug Administration (FDA) for VUZE 2.0, its second technology VUZE System. The brand new, investigational model of the VUZE System will likely be featured prominently at NASS 2023, the 38th annual assembly of the North American Spinal Society, which will likely be held October 18-21 in Los Angeles.
The VUZE System is a software program resolution put in on an off-the-shelf PC. It operates with unmodified surgical instruments, requires no markers, references or cameras, and without having for 3D imaging inside the working room (OR). Utilizing proprietary picture processing, it overlays in actual time graphical representations of ordinary surgical instruments seen in intra-operative 2D X-ray pictures onto axial and sagittal cross-sections that it generates from the affected person’s normal pre-operative 3D scan. The VUZE System beforehand acquired U.S. FDA 510(okay) clearance in 2022 and accomplished a profitable first-in-human scientific trial in early 2023. VUZE Medical has acquired eight associated patents so far within the U.S., Europe and Asia.
Attendees of NASS 2023 could have the chance to look at the investigational VUZE 2.0 in cadaveric surgical procedure in a Surgical Stadium session titled “Navigated MISS with No Instrument Modifications, References, Markers or Cameras” on October 19 from 11 a.m. to 12 p.m. PT. Palms-on experimentation will likely be obtainable at a cadaveric workshop on October 19 from 1 to 4 p.m. PT. Additional data will likely be offered on the VUZE Medical sales space #1051. Medical expertise will likely be reviewed in a Crimson Theater Presentation, “A New Strategy to Steering and Verification in MISS: Outcomes of First-in-Human Trial with the VUZE System,” on October 20 from 1 to 1:20 p.m. PT.
The second technology VUZE System is designed to help a broader vary of surgical C-arms from a number of distributors and accommodate extra sources of 3D picture information, together with each pre-operative CT and in-OR 3D scans. It additionally goals to supply expanded performance, together with the power to carry out surgical planning on a standalone laptop computer along with on the VUZE System.
“Our second technology goals to increase the operability of the VUZE System throughout a a lot bigger proportion of working rooms,” stated David Tolkowsky, founder and CEO of VUZE Medical. “The brand new options and performance may, as soon as cleared by FDA, make VUZE extra accessible and supply surgeons with simpler steering in conditions the place they beforehand didn’t have many engaging choices.”
Over three million surgical procedures for correcting spinal instability and/or deformation, collectively often called spinal stabilizations, are carried out yearly worldwide, with a 3rd of these within the U.S.1 These procedures embody vertebral fixation with pedicle screws, vertebral fixation coupled with fusion, and vertebral augmentation with artificial or organic cement. Roughly 80 % of stabilizations deal with quick spinal segments 1. Brief-segment surgical procedures are most frequently carried out manually and are usually assisted solely by normal 2D X-ray.
About VUZE Medical
VUZE Medical is a privately-held medical expertise firm that goals to supply extremely correct and cost-effective surgical steering for widespread spinal interventions at the moment aided solely by normal 2D X-Ray. The corporate’s VUZE System is a singular software-based resolution that immediately merges intra-operative X-ray with pre-operative CT, offering surgeons with the cross-sectional pictures they want most throughout surgical procedure and at the moment lack. The system is focused primarily at outpatient and ambulatory settings. For extra data, go to www.vuzemedical.com.
1. Orthopedic Community Information: 2020 Spinal Surgical procedure Replace
Pazanga Health Communications