See Instructions for Use for a complete list of warnings, precautions, and contraindications
  • MR Conditional

     

    Non-clinical testing1  demonstrated that the Carotid Stent is MR Conditional. A patient with this device can be scanned safely in an MR system immediately after placement under the following conditions:

    - Static magnetic field of 1.5-Tesla and 3-Tesla, only

    - Maximum spatial gradient magnetic field of 720-Gauss/cm (72-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 of operation for the MR system

    - Under the scan conditions defined, the Carotid Stent is expected to produce a maximum temperature rise of 1.7°C after 15-minutes of continuous scanning (i.e., per pulse sequence).

    Artifact Information

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

    1. 1

      Test Report TR12-203on file at MicroVention, Inc.