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DASI Dimensions is a standalone, non-invasive, clinical decision support software solution that is intended for use by cardiologists and radiologists in context of the aortic stenosis population. DASI Dimensions provides the end-user with pre-defined images and measurements (diameters, lengths, angles, areas, and perimeters) of cardiovascular structures. The clinician receiving the results the responsibility for interpreting and validating all information and making all patient treatment decisions. DASI Dimensions is not intended to replace the clinician's decision or device's instructions for use. DASI Dimensions is prescription use only.

DASI Dimensions is an image post-processing software system intended for clinical decision support in the context of pre-procedural planning of Transcatheter Aortic Valve Replacement (TAVR) procedures. The software provides users with a report of generated dimensions of cardiac structures. DASI Dimensions software is not operated by physicians. DASI Dimensions is an off-site software system that receives cardiologists input via upload of patient multiphase DICOM computed tomography angiography (CTA) chest image files through DASI Simulations web portal. The processed report is then available for viewing and downloading. The report is generated using proprietary algorithms that (a) detect key aortic root control points with the assistance of a static deep learning artificial intelligence (Al) model and (b) calculate anatomical measurements relevant for pre-TAVR evaluation. DASI Simulations engineers perform quality checks at both steps before releasing the report to the end user via the portal. DASI Dimensions does not contact with the patient, nor does it control any life sustaining devices. The information provided by DASI Dimensions is not diagnostic, nor does it determine recommended medical care. The cardiologists and/or radiologists receiving the responsibility for interpreting and validating all information and making all patient treatment decisions. DASI Dimensions: · Supports quantification of cardiac structures for pre-procedural planning of aotic stenosis patients in consideration for potential TAVR procedures. · Provides the measurement of different structures of the heart, e.g., aortic root, aortic valve.

PrecisionTAVI is an optional, non-invasive, post processing software solution that is indicated for patient-specific simulations of Transcatheter Aortic Valve Replacement (TAVR) during procedural planning. The software performs computer simulation to predict post TAVR in vivo valve frame deformation of clinician selected Transcatheter Heart Valve (THV) device types and sizes. The information provided by PrecisionTAVI is intended for use by cardiologists, and clinical specialists, and is not intended in any way to eliminate, replace, or substitute for, in part, the healthcare provider's judgment and analysis of the patient's condition receiving the images retains the responsibility for interpreting and validating all information and making all patient treatment decisions. PrecisionTAVI is not intended to replace the simulated device's instructions for use for final TAVR device selection and placement.

DASI Simulations PrecisionTAVI is a computer simulation device that predicts implant frame deformation after implantation of a Transcatheter Heart Valve (THV) device. The simulation combines a predefined THV device model and size with a patient-specific model of the patient's anatomy thereby predicting the post deployment deformation of the THV and the anatomy. The simulation results are intended to be used by qualified clinicians as additional information for planning transcatheter aortic valve replacement (TAVR). PrecisionTAVI conducts TAVR device deployment simulation using proprietary computational modeling technology. The input for the simulation is a 3D model of the patient anatomy. The 3D model is generated from 2D medical images of the patient anatomy (multi-slice Cardiac Computed Tomography). The simulation output is a report with 3D visualization capability to depict the predicted deformed THV in the deformed patient-specific anatomy of the aortic valve and root. The 3D model generation and the report generation from the simulation is performed by trained operators at DASI Simulations using an established workflow. The report is accessible to the end user as a download from the DASI Simulations portal with a standard web browser.