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  • Zenith Flex® AAA Endovascular Graft

    The MR safety and compatibility of the Zenith® AAA Endovascular Graft (a previous version of the device) has been evaluated through bench testing in MRI systems with static fields of ≤1.5 Tesla, gradient magnetic fields of ≤20 Tesla/second and whole body averaged specific absorption rate (SAR) of 1.2 W/kg for 30 minutes of imaging. The Zenith® AAA Endovascular Graft was found to exhibit significant deflection and torque of the stainless steel metallic component of the endovascular graft and therefore did not meet standard 'MR Safe' bench test criteria.

    Adverse events have not been reported clinically in patients who have undergone MRI. However, sufficient data are not available to demonstrate MRI safety and there may be potential risks (e.g., device migration, vessel damage) that could be associated with forces applied to the metallic components of the Zenith® AAA Endovascular Graft. Therefore, a careful assessment of these potential risks and the potential benefits to the patient should be completed prior to use of MR imaging. In addition, the facility for MRI should be appropriately selected to allow for prompt intervention if necessary.

    The Zenith AAA Endovascular Graft may affect the image quality (image artifact) depending on the pulse sequence that is used for MR imaging.

    Zenith Flex® MRI Compatibility Download

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  • Zilver® Self-Expanding Stent

    MRI CONDITIONS

    Non-clinical testing has demonstrated that the Zilver Self-Expanding Stent is MR Conditional. It can be scanned safely under the following conditions:

    • Static magnetic field of 3 Tesla or less
    • Spatial gradient field of 720 Gauss/cm or less
    • Whole body averaged specific absorption rate (SAR) of 1.5 W/kg (for a single stent at 1.5 Tesla) and 3 W/kg (for a single stent at 3 Tesla and a pair of overlapping stents at 1.5 and 3 Tesla) for 20 minutes (for a single stent at 1.5 Tesla) and 15 minutes of scanning (for a single stent at 3 Tesla and a pair of overlapping stents at 1.5 and 3 Tesla), respectively.

    In non-clinical testing, the Zilver Self-Expanding Stent produced maximum temperature rises of 0.1, 3.8, 0.8, and 0.1 degrees C (for a single stent at 1.5 Tesla, a pair of overlapping stents at 1.5 Tesla, a single stent at 3 Tesla, and a pair of overlapping stents at 3 Tesla, respectively) at whole body averaged specific absorption rates (SAR) of 1.5 W/kg (for a single stent at 1.5 Tesla) and 3 W/kg (for a single stent at 3 Tesla and a pair of overlapping stents at 1.5 and 3 Tesla) for 20 minutes (for a single stent at 1.5 Tesla) and 15 minutes (for a single stent at 3 Tesla and a pair of overlapping stents at 1.5 and 3 Tesla) of MR scanning in a 1.5 Tesla/64 MHz General Electric MR scanner, a 1.5 Tesla Magnetom Siemens Medical Solutions MR Scanner (to evaluate a pair of overlapping stents), and a 3 Tesla Excite General Electric MR scanner.

    MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the Zilver Self-Expanding Stent. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic implant.

    Heating in the MRI environment for stents with fractured struts is not known

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  • Gianturco-Roehm Bird’s Nest® Vena Cava Filter

    MRI-Safe: No additional risk to patients, but may affect the quality of the diagnostic information if scanning in the area of the filter.

    MRI diagnostic procedures should be postponed for 6 weeks following filter implantation to ensure device incorporation into the vessel wall.

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  • Günther Tulip™ Vena Cava Filter

    The Günther Tulip™ Vena Cava Filter is MRI Compatible with an MR scanner not exceeding 1.5 Tesla.

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  • MReye™ Needles for Magnetic Resonance Imaging

    COOK’s Interventional MReye™ needles are used for initial puncture and positioning control as well as biopsies and other interventional procedures in combination with Magnetic Resonance Imaging.

    • MReye™ products are created from a non-ferromagnetic material that helps prevent disturbing artifacts.
    • MReye™ needles are recommended for use with MRI scanners not exceeding 1.5 Tesla.

    To see different-sized images of the needle, try these scanner parameters:

    • To see an image of the needle at a ratio of 1:1, select a spin echo sequence (TR/TE 200ms/15ms).
    • To see an image of the needle enlarged approximately 2:1, select a gradient echo sequence (TR/TE/Flip angle 336 ms/15 ms/90°).
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  • Embolization Coils

    MR COMPATIBLE

    The following embolization coils are considered MR Compatible:

    • Nester Embolization Coils
    • MicroNester Embolization Coils
    • Tornado Embolization Coils
    • MicroTornado Embolization Coils
    • Platinum Detachable Embolization Coils
    • Hilal Embolization Coils

    “MR Compatible” indicates that the device, when used in the MR environment is MR Safe and has been demonstrated to neither significantly affect the quality of the diagnostic information nor have its operations affected by the MR device.

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  • Vital Ports

    Results of testing to assess MRI safety and compatibility using a 1.5 Tesla scanner provide reasonable assurance that the Vital-Port® system presents no additional risk or adverse effects in patients undergoing MRI. In titanium models, under worst case conditions using a gradient recalled pulse sequence (GRASS), image distortion may occur up to 5 cm within the location of the port body.

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  • Cook-Swartz Doppler Flow Probe

    WARNING–MR UNSAFE

    Do Not expose patient to an MRI procedure while Cook-Swartz Doppler Flow Probe is implanted. Substantial MRI-related heating of the Doppler Flow Probe may occur. Doppler Flow Probe must be removed prior to any MRI procedure.

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