AtriClip PRO2 Device

1. Data on file.
2. Starck, C.T. et al. (2012). Epicardial left atrial appendage clip occlusion also provides the electrical isolation of the left atrial appendage. Interactive cardiovascular and thoracic surgery, 15(3):416-18. This human clinical study demonstrated acute electrical isolation. Chronic electrical isolation has not been evaluated in human clinical studies.

INDICATIONS:
The AtriClip LAA Exclusion System is indicated for the exclusion of the heart’s left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

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).