FEops HEARTguide is a software tool that helps clinicians simulate and plan the implantation of left atrial appendage occlusion devices in individual patients. By using CT scans to create patient-specific heart models and incorporating device mechanics, it predicts how the device will deform and interact with the tissue, aiding pre-procedural decision-making to improve procedural outcomes and device placement.
Intended Use
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.
Technology
FEops HEARTguide creates patient-specific 3D models from pre-operative cardiac CT scans, incorporating mechanical behaviors of both tissue and implant device via Finite Element Analysis (FEA) to simulate device-tissue interaction and predict device morphology post-implantation.
Performance
Clinical accuracy validation was performed on 60 retrospective Watchman LAAO cases from 5 centers, comparing predicted device deformation on pre-op CT to post-op CT geometry. Quantitative agreement showed mean difference -1.9% with limits of agreement within ±15%, and qualitative assessment by cardiologists rated 90.6% of cases as clinically acceptable or better, supporting clinically acceptable accuracy for intended use.
Device Timeline
- 1
Submission
5/7/2020
1 year, 4 months - 2
FDA Approval
9/8/2021
Other devices from FEops NV
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.