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Zenith Spiral-Z MR Marking Statement

MRI Information

Non-clinical testing has demonstrated that the Zenith Spiral-Z AAA Iliac Leg Graft is MR Conditional. A patient with this endovascular graft can be scanned safely immediately after placement under the following conditions:

Static Magnetic Field

• Static magnetic field of 3.0 Tesla or less.
• Highest spatial magnetic gradient field of 720 Gauss/cm

Non-clinical evaluation was conducted in a 3 Tesla MR system (General Electric Excite) with a maximum spatial magnetic gradient field of 720 Gauss/cm as measured with a gaussmeter in the position of the static magnetic field pertinent to the patient (i.e., outside of scanner covering, accessible to a patient or individual).

MRI-Related Heating

1.5 Tesla Systems:

• Static magnetic field of 1.5 Tesla
• Maximum whole-body-averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning (i.e., per scanning sequence)

In non-clinical testing, the Zenith Spiral-Z AAA Iliac Leg produced a temperature rise of less than or equal to 2.1 °C at a MR system reported whole-body-averaged specific absorption rate (SAR) of 2.9 W/kg, 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 2.9 W/kg, which corresponds to a calorimetry measured value of 2.1 W/kg.

3.0 Tesla Systems:

• Static magnetic field of 3.0 Tesla
• Maximum whole-body-averaged specific absorption rate (SAR) of 2 W/kg for 15 minutes of scanning (i.e., per scanning sequence)

In non-clinical testing, the Zenith Spiral-Z AAA Iliac Leg produced a temperature rise of less than or equal to 2.6 °C at a MR system reported whole-body-averaged specific absorption rate (SAR) of 2.9 W/kg, for 15 minutes of MR scanning in a 3.0 Tesla Excite, GE Electric Healthcare, 14X. M5 Software, MR Scanner. The maximum whole-body-averaged specific absorption rate (SAR) was 2.9 W/kg, which corresponds to a calorimetry measured value of 2.7 W/kg.

Image Artifact

The image artifact extends throughout the anatomical region containing the device, obscuring the view of immediately adjacent anatomical structures within approximately 5 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, 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 100,000 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