Radiology DICOM image processing application software

Intended purpose

The device is indicated for patient-specific analysis of transcatheter device implantation during procedural planning. The software performs anatomical analysis and computer simulations to predict device-anatomy interaction to support physicians with their procedural planning with regard to the evaluation for device size and placement. The results are delivered and intended to be used by qualified clinicians in conjunction with the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment. FEops HEARTguide™ is not intended to replace the implant device instructions for use for final LAAO and TAVI device selection and placement.