Virage® Navigation System

Description

The Virage Navigation System is comprised of nonsterile, reusable instruments, including cases, drill bits, taps, and driver that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System to assist surgeons in precisely locating anatomical structures in procedures for preparation and placement of Virage OCT Spinal Fixation System polyaxial screws. This surgical imaging technology provides surgeons visualization for complex procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.

As with all orthopedic surgical procedures, detailed preoperative planning is essential. Preoperative diagnostic evaluation, followed by carefully executed surgical technique is required. Postoperative care, individualized to suit the particular injury/disease requirements, is essential for optimum outcome. The surgeon must be fully aware of the risks and complications inherent to this type of surgery. Only those individuals with specialized training and experience in spinal surgery should attempt use of the instruments.

The instrument cases may be one-layered with various inserts to hold surgical instrumentation in place during handling and storage. The inserts may contain holders. The instrument cases are perforated to allow steam to penetrate these various materials and components. The instrument cases will allow for sterilization of the contents to occur in a steam sterilizer utilizing a cycle that has been validated by the user for the equipment and procedures employed at the user facility. Instrument cases do not provide a sterile barrier and must be used in conjunction with a sterilization wrap or rigid container to maintain sterility.

Indications

The Virage® Navigation Instruments are to be used during the preparation and placement of Virage OCT polyaxial screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. The Virage Navigation Instruments are specifically designed for use with the Medtronic StealthStation® System, which 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 a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy. The Virage Navigation Instruments are also compatible with the ZimVie Universal Power System and the WalterLorenz® Surgical Assist Arm.

Contraindications

The Virage Navigation System is not designed or sold for any use except as indicated. DO NOT USE THE VIRAGE NAVIGATION SYSTEM INSTRUMENTS IN THE PRESENCE OF ANY CONTRAINDICATION.

Contraindications include, but are not limited to:

• Overt infection or distant foci of infections.
• Local inflammation, with or without fever or leukocytosis.
• Pregnancy.
• Morbid obesity.
• Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis.
• Suspected or documented metal allergy or intolerance.
• Any time implant utilization would interfere with anatomical structures or expedited physiological performance, such as impinging on vital structures.
• Severe comminuted fractures such that segments may not be maintained in satisfactory proximate 
• Use in displaced, non-reduced fractures with bone loss.
• The presence of m marked bone absorption or severe metabolic bone disease that could compromise the fixation achieved.
• Poor prognosis for good wound healing (e.g., decubitis ulcer, end-stage diabetes, severe protein deficiency,and/or malnutrition).
• Any case not needing a bone graft or fusion.
• Any case not described in the indications.
• The Virage Navigation System is contraindicated for any conditions listed as contraindications for the Medtronic Navigation System and the compatible Virage OCT Spinal Fixation System pedicle screws.

Warnings

• Refer to the Virage OCT system instructions for use for warnings related to use of the system during the surgical procedure.
• ZimVie does not warrant Medtronic Navigation Software. It is the sole responsibility of the user to ensure instrument calibration and/or registration.
• The use of the Virage Navigation System should only be used with the indicated Virage OCT Spinal Fixation System pedicle screws.
• Users must complete verification steps as required per the Medtronic Navigation Operative Technique.
• Users must ensure that surgical accuracy be assessed before the procedure and repeatedly throughout the procedure by positioning the tip of each navigated instrument on an identifiable anatomical landmark and comparing the actual tip location to that displayed by the system. When verifying the accuracy of the Navigated Drivers, the accuracy test must include the screw (of which diameter and length are selected/ entered into the software) assembled securely onto the driver. The screw tip will be placed on an identifiable anatomical landmark and compared to the tip location as displayed on the screen. 
• In the event of a registration failure or suspected inaccuracy, the Navigated Instruments should not be used with the Navigation System and the instruments should be inspected for damage before continuing with the traditional, non-navigated procedure.
• The Virage Navigation System instruments should not be bent or altered in any way as this couldlead to a reduction in system accuracy.
• ZimVie does not specify the maximum number of times a re-usable instrument may be re-used. The useful life of these instruments is highly dependent on a number of factors including the frequency and manner in which they are used and the handling they experience in between uses.

Precautions

• Refer to the system Instructions for Use for precautions related to use of the instruments with other system components and during the surgical procedure.
• Make sure to read all Instructions for Use for the system. Failure to read all instructions may result in misuse of the instruments or complications during surgery, resulting in harm to the patient.
• Do not subject instruments to excessive force as this may damage or fracture the instruments, resulting in impaired functionality of the instruments or debris from the instrument entering the incision and not being retrieved.
• Do not store or clean instruments with aggressive chemicals or contaminants as this may lead to an allergic reaction or other complication requiring medical attention.
• Unless otherwise indicated, instruments are supplied nonsterile. Instruments must be thoroughly cleaned and sterilized prior to each use.
• Failure to clean and sterilize instruments may result in an allergic reaction, infection of the incision, or other complication requiring medical attention.
• Do not use an instrument that has come in contact with a nonsterile surface, as the instrument may become contaminated and lead to infection of the incision.
• Do not use with vertebral components or instruments from other manufacturers or other ZimVie Spine systems unless specified.