AtriClip PRO2 Device

Page References

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

The LAA Exclusion System Clip is MR Conditional. A patient with the LAA Exclusion System Clip may be safely scanned under the following conditions. Failure to follow these conditions may result in injury to the patient:

• Nominal Values of Static Magnetic Field: 1.5-Tesla or 3.0-Tesla
• Maximum Spatial Field Gradient: 40 T/m (4,000 gauss/cm)
• Type of RF Excitation: Circularly Polarized (CP) (i.e., Quadrature Transmission)
• Transmit RF Coil Information: There are no transmit RF coil restrictions.
• Operating Mode of MR System: Normal Operating Mode
• Maximum Whole Body Averaged SAR: 2-W/kg (Normal Operating Mode)
• Limits on Scan Duration: Whole body averaged SAR of 2-W/kg for 60 minutes of continuous RF exposure (i.e., per pulse sequence or back-to-back sequences/series without breaks)
• MR Image Artifact: The presence of this implant produces an imaging artifact. Therefore, carefully select pulse sequence parameters if the implant is located in the area of interest.

PM-US-0310E-0826-G