Non-clinical testing demonstrated that the InterAtrial Shunt Device (IASD) 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 4,0000-Gauss/cm (extrapolated) or less
- Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 4-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 InterAtrial Shunt Device (IASD) is expected to produce a maximum temperature rise of 1.9°C after 15-minutes of continuous scanning (i.e., per pulse sequence).
In non-clinical testing, the image artifact caused by the InterAtrial Shunt Device (IASD) extends approximately 5-mm from this device when imaged using a gradient echo pulse sequence and a 3-Tesla MR system.