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MR Conditional

Non-clinical testing demonstrated that the SEALTM Embolization Device implant only is MR Conditional. It can be scanned safely under the following conditions:

  • Static magnetic field of 3-Tesla or less
  • Maximum spatial gradient field of 4,000-Gauss/cm (40-T/m)
  • Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode.

Under the scan conditions defined above, the SEALTM 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 SEALTM Embolization Device extends approximately 5 mm from the implant when imaged with a gradient echo pulse sequence and a 3-Tesla MRI system.

MR angiography may not be diagnostic due to the extent of the image artifact, and alternate vascular imaging is recommended. The SEALTM device may create local field inhomogeneity and susceptibility artifacts during magnetic resonance angiography (MRA), which may degrade the diagnostic quality to assess effective intracranial aneurysm treatment. Please only use digital subtraction angiography (DSA) or computed tomography angiography (CTA) to assess intracranial aneurysm occlusion for patient follow-up.

This type of information and manner of conveyance is consistent with the approaches from BSC and Stryker for conveying MRI Safety Information. While not required to be in place immediately, it should be live at the time of our IDE Submission.

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