AtriClip FLEX Device

MRI SAFETY INFORMATION:

MR CONDITIONAL
Non-clinical testing demonstrated that the LAA Exclusion System Clip 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.
• 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 4-W/kg for 15 minutes of scanning (i.e., per pulse sequence) in the First Level Controlled Operating Mode of operation for the MR system.
• The scan conditions defined for the LAA Exclusion System Clip are expected to produce a maximum temperature rise of 2.9°C (5.22°F) for Gillinov-Cosgrove Clip (LAA, ACH1, ACH2, PRO1, PRO2 devices) and 3.1°C (5.58°F) for V Clip (FLEX·V, PRO·V devices) after 15 minutes of continuous scanning (i.e., per pulse sequence).