X-ray system, diagnostic, computed tomography, application program software

Intended purpose

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.