AtriClip FLEX•V Device

A Simplified Approach to Left Atrial Appendage Exclusion

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Product Features

Tip first closure with continuous dynamic closing pressure
Intentionally designed with Dacron to support atraumatic placement and security in location
One-handed application with reduced fatigue clip opening lever
Suture-less clip deployment

The AtriClip Left Atrial Appendage Exclusion (LAAE) System is indicated for the exclusion of the heart’s Left Atrial Appendage (LAA), performed under direct visualization and in conjunction with other cardiac surgical procedures.

Isolation of Appendage

The AtriClip family of devices are the only Left Atrial Appendage Management (LAAM) devices clinically proven to provide both mechanical¹ and electrical isolation of the LAA.²

Class IA Recommendation

LAAM is now supported with Class IA recommendations from ACC/AHA and STS. This is based on decades of experience and clinical data supporting the efficacy and safety of the AtriClip System.

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A Simplified Approach to LAAE

AtriCure’s AtriClip devices are the most widely implanted LAAM devices in the world, providing a permanent solution to LAA exclusion during cardiac procedures.

700,000+

AtriClip Devices Sold

20+

Years of Expertise and Innovation in LAAM

90+

Published Studies Including AtriClip Devices

Over 20 Years of Innovation in LAAM

AtriCure has worked tirelessly to create a line of AtriClip devices that permanently exclude the LAA.

PRODUCT CODES:

ACHV35 (35 mm)
ACHV40 (40 mm)
ACHV45 (45 mm)
ACHV50 (50 mm)

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.

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-0305F-0726-G

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