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FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions. To facilitate the above, FEops HEARTguide™ ALPACA provides general functionality such as: - Segmentation of cardiovascular structures - Visualization and image reconstruction techniques: 2D review, MPR - Measurement and annotation tools - Reporting tools FEops HEARTguide™ ALPACA also allows visualization of output generated by other medical device software (e.g., FEops HEARTguide™ Simulation Application cleared as K214066). The results are 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™ ALPACA is not intended to replace the implant device instructions for use for final LAAO and TAVI device selection and placement.

FEops HEARTguide™ ALPACA enables visualization and measurement of structures of the heart and vessels for preprocedural planning and sizing of structural heart interventions. The software is used in a service-based business model: the customer (clinician) provides the necessary input data, FEops prepares the anatomical analysis, and delivers the results to the customer. The results of the anatomical analysis are provided to the clinician via FEops HEART guide™ ALPACA's web application. They are available in a PDF report and as interactive 3D and DICOM MPR visualizations. The web application is intended to be used by clinicians to review the results as well as to create additional landmarks and related measurements, if needed.

FEops HEARTguide™ 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. FEops HEARTguide™ is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, 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 simulated device instructions for use for final LAAO device selection and placement. FEops HEARTguide™ is prescription use only.

FEops HEARTguide™ predicts implant frame deformation after percutaneous LAAO device implantation through computer simulation. The predicted deformation provides additional information during LAAO procedural planning. The simulation is based on a 3D model of the patient anatomy which is generated from 2D medical images of the patient anatomy (multi-slice Cardiac Computed Tomography). The simulation is executed by FEops Case Analysts and run on FEops infrastructure. The simulation report is created by combining a predefined device model with a patient-specific model of the patient anatomy. This is performed by trained operators at FEops using an internal software platform through an established workflow. The purposely qualified case analysts and quality control analysts process the received medical images of the patient to produce the simulation results. The simulation results are provided as 2D and numerical data shown in a PDF report and 3D, 2D and numerical data shown in a web-based Viewer application accessible through a standard web browser.

FEops HEARTguide 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. FEops HEARTguide is intended to be used by qualified clinicians in conjunction with the simulated device instructions-for-use, 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 simulated device's instructions for use for final LAAO device selection and placement. FEops HEARTguide is prescription use only.

FEops HEARTguide is a computer simulation device which provides a prediction of implant frame deformation (device-tissue interaction) post transcatheter LAAO device implantation. The device performs simulation by combining a predefined device model with a patient-specific model of the patient anatomy (Figure 1). The simulation results are intended to be used by qualified clinicians as a pre-procedural planning adjunct for LAAO implantation.