WEB™ Embolization System Indications, Safety, and Warnings

MRI Safety Information

Non-clinical testing¹ demonstrated that the WEB™ Aneurysm Embolization Device is MR Conditional. A patient with this device can be scanned safely in an MR system under the following conditions:

- Static magnetic field of 3-Tesla 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 2-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode

Under the scan conditions defined, the WEB™ Aneurysm Embolization Device is expected to produce a maximum temperature rise of 1.4˚C after 15-minutes of continuous scanning (i.e., per pulse sequence).

In non-clinical testing, the image artifact caused by the WEB™ Aneurysm Embolization Device extends approximately 5-mm from this implant when imaged using a gradient echo pulse sequence and a 3-Tesla MR system.

MR Conditional
The WEB™ Aneurysm Embolization Device was determined to be MR-conditional.
Non-clinical testing demonstrated that the WEB™ Aneurysm Embolization Device is MR Conditional. A patient with this device can be scanned safely immediately after placement under the following conditions:

Static Magnetic Field

• Static magnetic field of 3-Tesla or less

• Maximum spatial gradient magnetic field of 4,000-Gauss/cm (extrapolated) or
  less

• Maximum MR system reported, whole body averaged specific absorption rate
  (SAR) of 2-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the
  Normal Operating Mode

MRI-Related Heating

Under the scan conditions defined above, the WEB™ Aneurysm Embolization Device is expected to produce a maximum temperature rise of +1.4° C after 15 minutes of continuous scanning.

Artifact Information

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 WEB™ Aneurysm Embolization Device.
Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary. In non-clinical testing, the artifact size (as imaged with a gradient echo pulse sequence and 3 Tesla MRI system) extends approximately 5-mm relative to the size and shape of the WEB™ Aneurysm Embolization Device.