Safety and Procedural Success of Left Atrial Appendage Exclusion With the Lariat Device: A Systematic Review of Published Reports and Analytic Review of the FDA MAUDE Database.
PMID: 25938303 ·
Saurav Chatterjee, Howard C Herrmann, Robert L Wilensky, John Hirshfeld, Daniel McCormick, David S Frankel, Robert W Yeh, Ehrin J Armstrong, Dharam J Kumbhani, Jay Giri
Abstract
The Lariat device has received US Food and Drug Administration (FDA) 510(k) clearance for soft-tissue approximation and is being widely used off-label for left atrial appendage (LAA) exclusion. A comprehensive analysis of safety and effectiveness has not been reported. To perform a systematic review of published literature to assess safety and procedural success, defined as successful closure of the LAA during the index procedure, of the Lariat device. We performed a formal analytic review of th
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