MRI INFORMATION

REF: GTS100L, GTS100R, G2-W, G2-M-IS, iS3, iS2

Static Magnetic field of 3 Tesla or less

Non-clinical testing has demonstrated that the stent(s) is/are MR Conditional.

A patient with this device can be safely scanned in an MR system meeting the following conditions:

  • Static magnetic field of 3T or less
  • Maximum spatial gradient magnetic field of 4,000 gauss/cm (40 T/m)
  • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4 W/kg

Under the scan conditions defined above, the stent(s) is/are not expected to produce a clinically significant temperature rise after 15 minutes of continuous scanning.

In non-clinical testing, the image artifact caused by the device extends less than 15 mm from the device when imaged with a gradient echo pulse sequence and a 3.0 T MRI system.

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