HeartFlow FFRct Analysis
HeartFlow, Inc.HeartFlow FFRct Analysis is a software tool that uses AI to analyze previously acquired coronary CT images (CT DICOM data). It creates a 3D computer model of the coronary arteries and simulates blood flow and pressure to help clinicians evaluate coronary artery disease. This aids in diagnosis and treatment planning by providing functional insights beyond traditional imaging.
Intended Use
HeartFlow Analysis is a coronary physiologic simulation software for clinical quantitative and qualitative analysis of previously acquired CT DICOM data to support functional evaluation of coronary artery disease in clinically stable symptomatic patients.
Technology
The device uses coronary CT angiography (cCTA) images to create an anatomic 3D model and an idealized model of coronary arteries, then applies computational fluid dynamics (CFD) solvers to simulate pressure, velocity, and blood flow for FFRCT calculation. The software outputs color-coded FFRCT analyses to aid clinical assessment.
Performance
The software was designed, developed, tested, and validated according to written procedures, including software testing of various FFRCT model modifications for vessel and lesion morphologies. Testing confirmed that the new CFD solver produced equivalent results to prior versions. Prior clinical data and predicate device reviews indicate the device is acceptable for use without new clinical studies.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/9/2019
4 months - 2
FDA Approval
8/15/2019
Other devices from HeartFlow, Inc.
- HeartFlow Analysis2022 • 510K
- HeartFlow Analysis2021 • 510K
- FFRct2018 • 510K
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