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VUZE Medical successfully concluded a 20-patient clinical study for its VUZE System evaluating safety, accuracy and user experience. The scope of the study was short-segment stabilizations in the thoracolumbar spine including fixations, fixations coupled with fusions and augmentations. The System received FDA 510(k) clearance in early 2022, and the company has received seven related patents so far in the U.S., Europe and Asia.
VUZE 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. 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% 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.
A 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.”
Source: VUZE Medical
VUZE Medical successfully concluded a 20-patient clinical study for its VUZE System evaluating safety, accuracy and user experience. The scope of the study was short-segment stabilizations in the thoracolumbar spine including fixations, fixations coupled with fusions and augmentations. The System received FDA 510(k) clearance in early 2022,...
VUZE Medical successfully concluded a 20-patient clinical study for its VUZE System evaluating safety, accuracy and user experience. The scope of the study was short-segment stabilizations in the thoracolumbar spine including fixations, fixations coupled with fusions and augmentations. The System received FDA 510(k) clearance in early 2022, and the company has received seven related patents so far in the U.S., Europe and Asia.
VUZE 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. 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% 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.
A 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.”
Source: VUZE Medical
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
