3. Overview
The
XVISION
-S
PINE
(
XVS
) system is a stereotactic image-guided navigation system designed to
assist surgeons in placing pedicle screws accurately, during open or percutaneous computer-
assisted spinal surgery. The system is designed to provide surgeons with an immersive 3D
and 2D visualization of patient’s anatomy through skin and tissue. The
XVS
system uses
optical tracking technology to display to the surgeon the real-time intraoperative location of
navigated surgical instruments relative to computed tomography acquired 2D images and 3D
reconstruction.
The
H
EADSET
of the
XVISION
-S
PINE
system displays two types of images: 2D stereotaxic screens
and a virtual screen displaying the 3D reconstructed model. The stereotaxic screens are
indicated for correlating the tracked instrument location to the registered patient imagery, and
the virtual screen is indicated for displaying the virtual tracked instrument location in relation
to virtual anatomy to assist in percutaneous visualization and trajectory planning.
The virtual display should not be relied upon solely for absolute positional information and
should always be used in conjunction with the displayed stereotaxic information.
The system should be used only as an adjunct for surgical guidance. It is not a replacement
for the surgeon’s knowledge, expertise, or judgment.
3.1. Intended Use
The
XVISION
-S
PINE
system, with the
XVISION
-S
PINE
S
YSTEM
S
OFTWARE
, is intended as an aid for
precisely locating anatomical structures in either open or percutaneous spine procedures.
Their use is indicated for any medical condition in which the use of stereotactic surgery may
be appropriate, and where reference to a rigid anatomical structure, such as the spine, can be
identified relative to CT imagery of the anatomy.
This can include the spinal implant procedures such as posterior pedicle screw placement in
the thoracic and sacro-lumbar region.
The
H
EADSET
of the
XVISION
-S
PINE
system displays 2D stereotaxic screens and a virtual
anatomy screen. The stereotaxic screen is indicated for correlating the tracked instrument
location to the registered patient imagery. The virtual screen is indicated for displaying the
virtual instrument location in relation to the virtual anatomy to assist in percutaneous
visualization and trajectory planning.
The virtual display should not be relied upon solely for absolute positional information and
should always be used in conjunction with the displayed stereotaxic information.
3.2. Intended User and Environment
The system is to be used by trained professionals only. These include surgeons, nurses and
technicians. The system is to be used only in an operating room.
3-1