MRI Statement

MR Conditional

Non-clinical testing demonstrated that the V-Wave Ventura® Interatrial Shunt is MR Conditional. A patient with this device can be safely scanned in an MR system under the following conditions:

  • Static magnetic field of 1.5 Tesla or 3-Tesla
  • 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 V-Wave Ventura Interatrial Shunt is expected to produce a maximum temperature rise of 1.8°C after 15-minutes of continuous scanning (i.e., per pulse sequence).

In non-clinical testing, the image artifact caused by the V-Wave Ventura Interatrial Shunt extends approximately 7-mm from this implant when imaged using a gradient echo pulse sequence and a 3-Tesla MR system.

MP-0011 rev 2.0

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