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.

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.

600,000+

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
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).

PM-US-0305F-0726-G

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