WEB™ Embolization System Indications, Safety, and Warnings
See Instructions for Use for a complete list of warnings, precautions, and contraindications
MRI Safety Information
Non-clinical testing 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:1
- 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.
1Test Report TR14-241-01on file at Terumo Neuro.