MRI Compatibility
Zenith Flex® AAA Endovascular Graft
(excerpted from IFU)
Zenith Flex AAA Endovascular Graft MRI Safety and Compatibility Download
MRI Safety and Compatibility
Non-clinical testing has demonstrated that the Zenith AAA Endovascular Graft is MR Conditional. It can be scanned safely under the following conditions:
1.5 Tesla Systems:
- Static magnetic field of 1.5 Tesla
- Spatial gradient field of 450 Gauss/cm
- Maximum whole body averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning
In non-clinical testing, the Zenith AAA Endovascular Graft produced a temperature rise of less than or equal to 1.4 °C at a maximum whole body averaged specific absorption rate (SAR) of 2.8 W/kg, as assessed by calorimetry for 15 minutes of MR scanning in a 1.5 Tesla Magnetom, Siemens Medical Magnetom, Numaris/4 Software, Version Syngo MR 2002B DHHS MR Scanner. The maximum whole body averaged specific absorption rate (SAR) was 2.8 W/kg, which corresponds to a calorimetry measured value of 1.5 W/kg.
3.0 Tesla Systems:
- Static magnetic field of 3.0 Tesla
- Spatial gradient field of 720 Gauss/cm
- Maximum whole body averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning
In non-clinical testing, the Zenith AAA Endovascular Graft produced a temperature rise of less than or equal to 1.9 °C at a maximum whole body averaged specific absorption rate (SAR) of 3.0 W/kg, as assessed by calorimetry for 15 minutes of MR scanning in a 3.0 Tesla Excite, GE Electric Healthcare, G3.0-052B Software, MR Scanner. The maximum whole body averaged specific absorption rate (SAR) was 3.0 W/kg, which corresponds to a calorimetry measured value of 2.8 W/kg.
The image artifact extends throughout the anatomical region containing the device, obscuring the view of immediately adjacent anatomical structures within approximately 20 cm of the device, as well as the entire device and its lumen, when scanned in nonclinical testing using the sequence: Fast spin echo, in a 3.0 Tesla, Excite, GE Electric Healthcare, with G3.0-052B software, MR system with body radiofrequency coil.
For all scanners, the image artifact dissipates as the distance from the device to the area of interest increases. MR scans of the head and neck and lower extremities may be obtained without image artifact. Image artifact may be present in scans of the abdominal region and upper extremities, depending on distance from the device to the area of interest.
Clinical information is available for seventeen patients who received MRI scans after stent-graft implantation. There have been no reported adverse events or device problems in any of these patients as a result of having received an MRI. Additionally, there have been well over 50,000 Zenith AAA Endovascular Grafts implanted worldwide, in which there have been no reported adverse events or device problems as a result of MRI.
Cook Recommends that the patient register the MR conditions disclosed in this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be contacted in the following manners.
| Mail: | MedicAlert Foundation International 2323 Colorado Avenue Turlock, CA 95382 |
| Phone: | 888-633-4298 (toll free) 209-668-3333 from outside the US |
| Fax: | 209-669-2450 |
| Web: | www.medicalert.org |
Cook Celect™ Vena Cava Filter
Non-clinical testing has demonstrated that the Cook Celect Vena Cava Filter is MR Conditional. It can be scanned safely immediately after placement under the following conditions:
- Static magnetic field strengths of 3.0 Tesla or less
- Maximum spatial gradient field of 330 gauss/cm or less
- Maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of scanning
In non-clinical testing, the Cook Celect Vena Cava Filter produced a temperature rise of less than 0.2 degrees C at a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR scanning in a 3.0 Tesla MR system using a transmit/receive body coil 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 Cook Celect Vena Cava Filter. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic implant.
Zilver® Self-Expanding Stent
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.
Embolization Coils - Stainless Steel
Stainless steel coils are ferrous and are affected by the MR field. Bench top testing on stainless steel embolization coil samples showed high degrees of torque and deflection. Therefore, stainless steel embolization coils have a designation of MR Unsafe and we would not recommend a patient implanted with a stainless steel embolization coil be scanned.
Gianturco-Roehm Bird’s Nest® Vena Cava Filter
MR-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 procedrues should be postponed for 6 weeks following filter implantation to ensure device incorporation into the vessel wall.
Formula 418® Balloon Expandable Biliary Stent
Non-clinical testing has demonstrated that the Formula Biliary Stent is MR Conditional. A patient with this stent may undergo MRI immediately after placement under the following conditions:
- Static magnetic field of 3.0 Tesla or less
- Maximum spatial gradient magnetic field of 720 gauss/cm
- Maximum MR system reported whole body averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes of scanning
In non-clinical testing, the Formula Biliary Stent produced a temperature rise of less than 1 degree C at an MR system reported maximum whole body averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of MR scanning in a 3 Tesla, Excite, Software G3.0-052B, General Electric Medical Systems 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 Formula Biliary Stent. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic implant. The effect of heating in the MRI environment for overlapping stents or stents with fractured struts is unknown.
Günther Tulip™ Vena Cava Filter
Non-clinical testing has demonstrated that the Günther Tulip Vena Cava Filter is MR Conditional. It can be scanned safely immediately after placement under the following conditions:
- Static magnetic field strengths of 3.0 Tesla or less
- Maximum spatial gradient field of 525 gauss/cm or less
- Maximum whole body averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes of scanning
In non-clinical testing, the Günther Tulip Vena Cava Filter produced a temperature rise of less than 0.6 degrees C at a maximum whole body averaged specific absorption rate (SAR) of 3.0 W/kg for 15 minutes of MR scanning in a 3.0 Tesla MR system using a transmit/receive body coil (Excite, Software G3.0-052B, General Electric Healthcare, Milwaukee, WI) 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 Günther Tulip Vena Cava Filter. Therefore, it may be necessary to optimize MR imaging parameters for the presence of this metallic implant.
Hilal Embolization Microcoils™
Hilal Embolization Coils are manufactured from a platinum composition, which has been shown to have no ferromagnetic response. Through non-clinical testing, embolization coils manufactured of this material have been shown to be MR Conditional. A patient with one of these implants can be scanned safely immediately after placement under the following conditions:
- Static magnetic field strengths of 3.0 Tesla or less
- Maximum spatial gradient field of 330 gauss/cm
- Maximum MR system whole-body-averaged specific absorption rate (SAR) of 3-W/kg for 15 minutes of scanning
In this testing, platinum embolization coils produced a temperature rise of greater than 0.5 degrees C at a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 20 minutes of MRI. The effect of heating for other conditions, multiple coils or overlapping coils is unknown.
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of platinum embolization coils.
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.
MReye® Embolization Coils
Through non-clinical testing, the MReye Embolization Coil has been shown to be MR Conditional. It can be scanned safely immediately after placement under the following conditions:
- Static magnetic field strengths of 3.0 Tesla or less
- Maximum spatial gradient of 330 gauss/cm
- Maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 20 minutes of MRI
The MReye Embolization Coil will not migrate in this MRI environment. Non-clinical testing has not been performed to rule out the possibility of device migration at static magnetic field strengths higher than 3.0 Tesla and a maximum spatial gradient higher than 330 gauss/cm.
In this testing, the MReye Embolization Coil produced a temperature rise of greater than or equal to 0.6 degrees C at a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 20 minutes of MRI. The effect of heating in the MRI environment for other conditions, multiple coils or overlapping coils is unknown.
MRI image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the MReye Embolization Coil.
MReye Flipper® Detachable Embolization Coils
Through non-clinical testing, the MReye Flipper Detachable Embolization Coil Delivery System has been shown to be MR Conditional. It can be scanned safely immediately after placement under the following conditions:
- Static magnetic field strengths of 3.0 Tesla or less
- Maximum spatial gradient of 330 gauss/cm
- Maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 20 minutes of MRI
Embolization coils manufactured of Inconel will not migrate in this MRI environment. Non-clinical testing has not been performed to rule out the possibility of device migration at static magnetic field strengths higher than 3.0 Tesla and a maximum spatial gradient higher than 330 gauss/cm.
In this testing, the MReye Embolization Coil produced a temperature rise of greater than or equal to 0.6 degrees C at a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 20 minutes of MRI. The effect of heating in the MRI environment for other conditions, multiple coils or overlapping coils is unknown.
MRI image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the MReye Embolization Coil.
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 200 ms/15 ms).
- 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°).
Nester® Embolization Coils
Nester Embolization Coils are manufactured from a platinum composition, which has been shown to have no ferromagnetic response. Through non-clinical testing, embolization coils manufactured of this material have been shown to be MR Conditional. A patient with one of these implants can be scanned safely immediately after placement under the following conditions:
- Static magnetic field strengths of 3.0 Tesla or less
- Maximum spatial gradient field of 330 gauss/cm
- Maximum MR system whole-body-averaged specific absorption rate (SAR) of 3-W/kg for 15 minutes of scanning
In this testing, platinum embolization coils produced a temperature rise of greater than 0.5 degrees C at a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 20 minutes of MRI. The effect of heating for other conditions, multiple coils or overlapping coils is unknown.
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of platinum embolization coils.
Tornado® Embolization Coils
Tornado Embolization Coils are manufactured from a platinum composition, which has been shown to have no ferromagnetic response. Through non-clinical testing, embolization coils manufactured of this material have been shown to be MR Conditional. A patient with one of these implants can be scanned safely immediately after placement under the following conditions:
- Static magnetic field strengths of 3.0 Tesla or less
- Maximum spatial gradient field of 330 gauss/cm
- Maximum MR system whole-body-averaged specific absorption rate (SAR) of 3-W/kg for 15 minutes of scanning
In this testing, platinum embolization coils produced a temperature rise of greater than 0.5 degrees C at a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 20 minutes of MRI. The effect of heating for other conditions, multiple coils or overlapping coils is unknown.
MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of platinum embolization coils.
Vital Port® System
Non-clinical testing demonstrated that the Vital-Port Vascular Access Ports are MR Conditional. A patient with one of these implants can be scanned safely immediately after placement under the following conditions:
- Static magnetic field of 3.0 Tesla or less
- Maximum spatial gradient magnetic field of 720 gauss/cm
- Maximum MR system reported whole-body-averaged specific absorption rate (SAR) of 3W/kg for 15 minutes of scanning
In non-clinical testing, the vascular access ports, produced maximum temperature increases of less than or equal to 0.7 degrees C at maximum MR system-reported whole body averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of MR scanning in a 3 Tesla MR system using a transmit/receive body coil (Excite, Software G3.0-052B, General Electric Healthcare, Milwaukee, WI).
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 vascular access ports. Therefore, it may be necessary to optimize MR imaging parameters to compensate for the presence of one of these implants.
Zenith TX2® TAA Endovascular Graft
(excerpted from IFU)
Zenith TX2 MRI Compatibility Download
Non-clinical testing has demonstrated that the Zenith TX2 TAA Endovascular Graft is MR Conditional. It can be scanned safely under the following conditions:
1.5 Tesla Systems:
- Static magnetic field of 1.5 Tesla
- Spatial gradient field of 450 Gauss/cm
- Maximum whole-body-averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning
In non-clinical testing, the Zenith TX2 TAA Endovascular Graft produced a temperature rise of less than 1.4°C at a maximum whole-body-averaged specific absorption rate (SAR) of 2.8 W/kg for 15 minutes of MR scanning in a 1.5 Tesla Magnetom, Siemens Medical Magnetom MR scanner. The maximum whole-body-averaged specific absorption rate (SAR) was 2.8 W/kg, which corresponds to a calorimetry measured value of 1.5 W/kg.
3.0 Tesla Systems:
- Static magnetic field of 3.0 Tesla
- Spatial gradient field of 720 Gauss/cm
- Maximum whole-body-averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning
In non-clinical testing, the Zenith TX2 TAA Endovascular Graft produced a temperature rise of less than 1.9°C at a maximum whole-body-averaged specific absorption rate (SAR) at 3.0 W/kg for 15 minutes of MR scanning in a 3.0 Tesla, Excite, GE Electric Healthcare MR scanner. The maximum whole-body-averaged specific absorption rate (SAR) was 3.0 W/kg, which corresponds to a calorimetry measured value of 2.8 W/kg.
The image artifact extends throughout the anatomical region containing the device, obscuring the view of immediately adjacent anatomical structures within approximately 20 cm of the device, as well as the entire device and its lumen, when scanned in non-clinical testing using the sequence: Fast spin echo in a 3.0 Tesla, Excite, GE Electric Healthcare, with G3.0-052B software, MR system with body radiofrequency coil.
For all scanners, the image artifact dissipates as the distance from the device to the area of interest increases. MR scans of the lower extremities may be obtained without image artifact. Image artifact may be present in scans of the abdominal, upper extremity, and head and neck region, depending on distance from the device to the area of interest.
Clinical information is available on six patients who received MRI scans during the course of the clinical trial. There have been no reported adverse events or device problems in any of these patients as a result of having received an MRI. Additionally, there have been approximately 3,000 patients implanted with Zenith TAA Endovascular Grafts worldwide, in which there have been no reported adverse events or device problems as a result of MRI.
Cook recommends that the patient register the MR conditions disclosed in this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be contacted in the following manners:
| Mail: | MedicAlert Foundation International 2323 Colorado Avenue Turlock, CA 95382 |
| Phone: | 888-633-4298 (toll free) 209-668-3333 from outside the US |
| Fax: | 209-669-2450 |
| Web: | www.medicalert.org |