Thursday, May 30, 2024
VUZE Medical, a privately-held company dedicated to advancing intra-operative guidance for spinal interventions traditionally aided by X-ray, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its second-generation VUZE System.
This system, initially targeting minimally invasive thoracolumbar stabilizations, has the potential for broader applications across various anatomical regions. The company plans to seek regulatory clearances for additional spinal and skeletal interventions.
VUZE Medical holds eleven patents across the U.S., Europe, China, and India, covering innovations in robotics, augmented reality (AR), and traditional hardware-based navigation.
The VUZE System is a software solution installed on a standard PC, designed to work with unmodified surgical tools without requiring markers, references, or cameras.
It offers optional 3D imaging in the operating room (OR) by using proprietary image processing algorithms to overlay real-time graphical representations of surgical tools seen in 2D X-ray images onto axial and sagittal cross-sections derived from the patient’s pre-operative 3D scan.
The system received its initial FDA 510(k) clearance in 2022 and completed its first human clinical trial in 2023.
The second-generation VUZE System expands its support to a wider range of surgical C-arms from all major vendors and accommodates more 3D image data sources, including both pre-operative CT and in-OR CT/CBCT scans. It also allows for surgical planning on a compatible standalone laptop, as well as on the VUZE System itself.
Second generation significantly extends the applicability of the VUZE System across various surgical workflows and operating room setups. Aim to preserve the benefits of traditional X-ray guidance while addressing its limitations.”
Annually, over three million surgeries to correct spinal instability or deformation, known as spinal stabilizations, are performed worldwide, with up to a third taking place in the U.S.
These procedures include vertebral fixation with pedicle screws, vertebral fixation with fusion, and vertebral augmentation with synthetic or biological cement.
Most of these surgeries treat short spinal segments, typically using standard 2D X-ray guidance. Studies have shown that pedicle screw misplacement is more likely with X-ray guidance compared to navigated surgery.
Source: businesswire.com
