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TruPlan enables visualization and measurement of structures of the heart and vessels for: - · Pre-procedural planning and sizing for the left atrial appendage closure (LAAC) procedure - · Post-procedural evaluation for the LAAC procedure To facilitate the above, TruPlan provides general functionality such as: - · Segmentation of cardiovascular structures - · Visualization and image reconstruction techniques: 2D review, Volume Rendering, MPR - · Simulation of TEE views, ICE views, and fluoroscopic rendering - · Measurement and annotation tools - · Reporting tools TruPlan's intended patient population is comprised of adult patients.

The TruPlan Computed Tomography (CT) Imaging Software application ("TruPlan") is a software as a medical device that helps qualified users with image-based pre-procedural planning and post-procedural follow-up of the Left Atrial Appendage Closure (LAAC) procedure using CT data. TruPlan is designed to support the anatomical assessment of the Left Atrial Appendage (LAA) prior to and following the LAAC procedure. This includes the assessment of the LAA size, shape, and relationships with adjacent cardiac and extracardiac structures. This assessment helps the physician determine the size of a closure device needed for the LAAC procedure and evaluate LAAC device placement in a follow-up CT study. The TruPlan application is a visualization software and has basic measurement tools. The device is intended to be used as an aid to the existing standard of care and does not replace existing software applications physicians use for planning or follow-up for a LAAC procedure.