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Hi-D Imaging 4TAVR is a software as a medical device (SaMD) intended to support trained healthcare professionals (cardiologists, radiologists, clinical specialists) with the assessment of the cardiovascular anatomy and visualization and measurement of structures of the heart and vessels, including the aortic valve, and with pre-operational planning and sizing for transcatheter aortic valve replacement (TAVR) procedures by providing: - Automatic segmentation of the full heart and vessels - 3D and 2D rendering of DICOM images - Automatic centerline detection - Automatic detection of the LVOT (left ventricular outflow tract), aortic, sinus, sinotubular junction (STJ), ascending aorta and descending aorta planes - Automatic multiplanar reconstruction (MPR) based on the centerline - Measurement and visualization tools - Manual measurement option for the user - Automatic S-curve extraction - Automatic report generation Hi-D Imaging 4TAVR software is indicated for patients with tricuspid aortic stenosis who are eligible for TAVR operations and without any prior aortic valve implants.

Hi-D Imaging 4TAVR ("the Device" or "4TAVR") is a cloud-based software as a medical device (SaMD) intended for use by healthcare professionals for the anatomy assessment of cardiac structures prior to Transcatheter Aortic Valve Replacement (TAVR) operations. 4TAVR enables healthcare professionals to maximize information using CT scan data and provide support for patient-specific pre-procedural planning of TAVR operations. 4TAVR utilizes an artificial intelligence (AI) deep learning model and computer vision methods that provide: 1) Fast and reliable automated analysis, 2) Fully automated segmentation of CT-based cardiac anatomy data, 3) 3D reconstruction and visualization of the anatomy, and 4) Fully automated report generation. The main features of 4TAVR are: - Fully automated extraction of heart components; - Multiplanar reconstruction of the clinically-relevant anatomical planes for TAVR operations (i.e., left ventricular outflow tract (LVOT), annulus, sinus, sinotubular junction (STJ), ascending aorta, and descending aorta); - 3D surface rendering of each heart component, including centerline detection; - Fully automated detection and calculation of clinically relevant anatomical parameters such as annular perimeter, annular area, annular minimal and maximal diameter, LVOT diameter, ostium left main height and right coronary artery height, sinus of Valsalva, ascending and descending aorta perimeters, areas and diameters, sinotubular junction diameter and calcification for TAVR planning; and - 3D downloadable meshes of aorta, left ventricle, left atrium, myocardium, right ventricle, calcium, and pulmonary artery. 4TAVR automatically processes DICOM images uploaded by the user and reports the results back to the user. The results include automatically generated measurements, 2D and 3D segmentation visualization, and a comprehensive report.