Product Features
- First AtriClip device designed for minimally invasive concomitant surgery with the AtriClip Mini, which is 60% smaller than the next lowest profile AtriClip1
- Maintains the same durability, safety profile and stability as existing AtriClip devices1
- Applies uniform pressure to ensure consistent, reproducible and secure placement with the AtriClip Mini1
1Data on file
The AtriClip PRO-Mini 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.
Direct visualization, in this context, requires that the surgeon can see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.
The Next Generation AtriClip
The AtriClip Mini uses the same fabric as existing AtriClips now designed with a tighter weave that is form fitting in nature for optimized visualization and a smaller footprint.
Consistent Range of Motion
Greater than 30° Pitch (up and down) and yaw (side to side).
New AtriClip Device for Minimally Invasive Surgical Procedures
AtriClip PRO-Mini combines familiar and trusted applier technology with the next generation AtriClip for consistent and reproducible exclusion.
Total Exclusion Results in Complete
Electrical Isolation1,2
AtriClip Mini has an LAA exclusion rate that is equivalent to existing AtriClips.1,2
The AtriClip PRO-Mini device maintains the excellence of AtriClip devices through epicardial exclusion, continuous dynamic closing pressure, parallel closure and atraumatic tissue compression.1
- Data on file.
- 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.
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PRODUCT CODES:
- PROM35
- PROM40
- PROM45
- PROM50
Page References
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-4551A-0427-G
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Product Labeling and Instructions for Use