The FEops HEARTguide Simulation Application is a specialized software tool that assists clinicians in planning heart implant procedures by simulating the deformation of cardiac device implants. It uses patient-specific 3D anatomical models derived from medical imaging to predict how a left atrial appendage occlusion device will fit, helping clinicians choose the right device size and placement before surgery.
Intended Use
FEops HEARTguide Simulation Application is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning. The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement. It is intended to be used by qualified clinicians alongside clinical data and simulated device instructions for use, but not to replace final device selection and placement decisions.
Technology
FEops HEARTguide creates computational models of patient-specific cardiac anatomy combined with predefined models of the implant device. Simulations are conducted by trained analysts, delivering results as 3D visualizations and reports accessible via a web browser. The software architecture includes integration with FEops HEARTguide ALPACA for report delivery. The subject device adds support for the Boston Scientific Watchman FLX Pro device while maintaining the same modeling strategy and simulation workflow.
Performance
Clinical performance data were included demonstrating validation of the software for its intended use, showing similar performance to the previously cleared predicate device.
Predicate Devices
No predicate devices specified
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