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I contenuti presenti nella pagina che segue contengono informazioni rivolte esclusivamente agli OPERATORI SANITARI, in quanto si riferiscono a prodotti rientranti nella categoria dei dispositivi medici che richiedono l’impiego o l’intervento da parte di professionisti del settore medico-sanitario.
The Mazor X™ Stealth Edition robotic guidance platform combines advanced software, robotic technology, navigation, and instrumentation to help you to deliver high-quality care and supports your commitment to accurate and precise trajectory guidance for your surgical procedures. We give you the algorithm to look beyond individual pedicles to construct design and provide you with cutting-edge robotic and navigation technology to achieve your surgical goals.
Predictability of Planning
Planning is the foundation to a robotic guidance solution. The plan provides the surgeon with the insight on what they would like to achieve, taking under consideration the needs of each patient. With this uniqueness there is inherent unpredictability with each procedure. Planning provides the ability to make the procedure predictable.
Precision of Robotic Guidance
Once a plan has been created, it is unlikely that a surgeon will be able to execute the plan without additional help from technology. The software guides the Surgical Arm into position, translating the Surgical Plan to precision trajectory guidance in the surgical field. Our technology is designed specifically to help create precision and predictability.
visibility of navigation
Although the robot brings precision, there are two elements that are not provided. The first is the 5th degree of freedom, or depth of the screw. Depth of the screw is another variable that needs to be monitored to execute the procedure plan. Navigation provides this final degree of freedom in addition to that provided by robotic guidance.
Beyond that, the surgeons are looking for assurance and real-time reconciliation of their work back to the plan. In simple terms, they would like to see where they are relative to their patient and relative to their plan. Navigation provides visibility in this step that closes the loop on the execution phase of the process.
EXPERIENCE
A third-generation surgical robotic guidance system and eighth-generation navigation system, Mazor X Stealth Edition builds on years of experience. In its first year, the Mazor X robotic guidance system was used in more than 1,000 procedures in more than 50 hospitals in the United States, and since inception, StealthStation™ technology has been used in over 100,000 procedures.*
CONTINUALLY INNOVATIVE
We believe technology has the power to improve lives. That's why we are continually innovating to bring you the latest in spine surgical imaging, navigation, robotic technology, and implant therapies.
INDICATIONS
The Mazor X is indicated for precise positioning of surgical instruments or spinal implants during general spinal and brain surgery. It may be used in either open or minimally invasive or percutaneous procedures.
Mazor X 3D imaging capabilities provide a processing and conversion of 2D fluoroscopic projections from standard C-Arms into volumetric 3D image. It is intended to be used whenever the clinician and/or patient benefits from generated 3D imaging of high contrast objects.
The Mazor X navigation tracks the position of instruments, during spinal surgery, in relation to the surgical anatomy and identifies this position on diagnostic or intraoperative images of a patient.
PRODUCT DETAILS
How it Works
Proactively plan while achieving stability and accuracy
The Mazor X Stealth Edition robotic guidance system allows for pre-operative or intra-operative planning and robotic and image-guided execution of multiple trajectories. The power of the platform is a preoperative planning suite with 3D analytics and tools that allow surgeons to work towards construct optimization. With our innovative imaging cross-modality registration process, each vertebral body registers independently, and the robotic system analyzes and pairs images from different modalities, such as matching a preoperative CT with intraoperative fluoroscopy or 3D surgical imaging. On surgery day, the plan is realized using robotic-guided execution and real-time visualization, enabling a predictable procedure with defined trajectories, preselected implants, and no anatomical surprises.
Accuracy in Surgical Planning
Sophisticated 3D analytics and virtual tools allow you to determine procedural goals and create a "surgical blueprint" prior to the case. On surgery day, the plan is executed through efficient movements, enabling a predictable procedure — complete with defined trajectories, preselected implants, and no anatomical surprises. This plan takes into account construct design and global alignment, going beyond single trajectory guidance.
Advanced Anatomy Recognition
Based on advanced algorithms, the Mazor X Stealth Edition anatomy recognition software reads — and recognizes — anatomical features offering pre-operative insight to the challenges before you. The software is fundamental to planning and serves as the underlying technology supporting key features such as vertebral segmentation, image registration, and alignment calculations.
Secure Patient Connection Platform
Precise robotic-guided execution centers around a stable connection to the patient. Our biocompatible devices rigidly affix the robotic guidance system to the patient’s skeletal anatomy during surgery, ensuring precision through a secure, solid connection.
Cross-Modality Image Registration
With an innovative imaging cross-modality registration process, each vertebral body registers independently. The robotic guidance system analyzes and pairs images from different imaging modalities, such as matching a pre-operative CT with intra-operative fluoroscopy — or 3D surgical imaging, like the O-arm System — including images captured at different times and on different anatomical planes.
Best-in-Class Navigation
With innovative imaging real-time visualization, you are able to execute your operative plan with Stealth Navigation technology. Based on decades of experience, the navigation suite allows you to visualize the implant entering the anatomy relative to your plan and execute your procedure intra-operatively with trust. Surgeons are looking for assurance and real time reconciliation of their work back to the plan. In simple terms, they would like to see where they are relative to their patient and relative to their plan. Navigation provides the visibility in this step the closes the loop on the execution phase of the process.
Implant Placement Planning
During sacroiliac (SI) joint fusion procedures, Mazor X Stealth Edition can allow surgeons to plan and execute SI screw and implant placement with minimally invasive or percutaneous methods. Planning the final location for SI screws may make placement more straightforward by potentially avoiding constant confirmation checks using the C-arm.
FEATURES
Robotic Guided Spine Surgery
The Mazor X Stealth Edition is a robotic arm solution with goals to advance precise arm solutions for each trajectory. This robotic-guided spine surgery is based on foundational software that allows you to plan intra-operatively or pre-operatively.
The Mazor X Stealth Edition robotic guidance arm makes it possible to:
Achieve simultaneous complex movements and reach
Create multiple arm position options for each desired trajectory
Analytical Software for 3D Imaging
The Mazor X Stealth Edition software intelligence goes beyond single pedicle trajectory guidance. The system can enable construct optimization and spinal balance, allowing you to:
Use image processing capabilities to identify and segment out individual vertebral bodies on an image
Use the images to plan many of the pre-operative elements of your procedure and merge individual segment images and associated plans with the patient's actual position on the table
Plan difficult pedicle screw trajectories with 3D implants customized for your selected system
Plan screw head positioning and rod geometry to optimize rod fixation and placement
Structure order of operations for screw placement in the procedure
Create a customized 3D preoperative plan (in advance or after the O-arm image acquisition) on the workstation or a computer located elsewhere
Identify pre-operative global balance parameters in a physiologic environment (3D virtual weight-bearing CT or other surgical imaging device) and plan surgical interventions to achieve optimal balance
Plan intervertebral positioning and type of system needed for the procedure
Identify optimal incision length and location for MIS approaches
StealthStation Navigation Technology
The intuitive StealthStation technology enables clear visualization and surgical navigation of the segments in the spine. Whether your practice make-up is single-level degenerative, deformity correction, lateral access, or cervical procedures — the StealthStation technology allows for visualization of the execution of your robotic guidance procedure plan. The complete procedural solution seamlessly integrates with the robotic guidance technology, and our broad portfolio of Medtronic navigated spinal instruments and implants.
Streamlined OR Footprint
A unique, bed-mounted robotic guidance system lets you pull the workstation away from the operating table to minimize risk of crowding during the procedure. This:
Allows anesthesiology to maintain their routines and locations relative to patients
Maintains your preferred location relative to the patient
Provides the option to bring in or remove the workstation from the sterile field based upon procedural situation or your team preferences
Proprietary image processing capabilities on a CT or other surgical imaging device make it possible to identify and segment out individual vertebral bodies level by level, which provides 3D axial, coronal, and sagittal slice data to help you plan.
The Mazor X Stealth Edition robotic guidance system understands its 3D environment and knows where it can and cannot move, creating efficient and faster movements during implantation.
MANUALS AND TECHNICAL GUIDES
Find the Mazor X Stealth Edition system technical manual in the product labeling supplied with each system or call Medtronic at 800-961-9055.
*
Source: Mazor Robotics sales and hospital data, as of December 2017.
