FFRct
HEARTFLOW, INC.HeartFlow FFRct is a software tool that analyzes previously acquired coronary CT images to simulate coronary blood flow and pressure, aiding clinicians in evaluating coronary artery disease without additional invasive procedures. It provides functional assessment by generating fractional flow reserve values to support clinical decision-making alongside other diagnostic information.
Intended Use
HeartFlow FFRCT is a coronary physiologic simulation software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides FFRCT, a mathematically derived quantity, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. FFRCT analysis is intended to support the functional evaluation of coronary artery disease. The results of this analysis are provided to support qualified clinicians to aid in the evaluation and assessment of coronary arteries. The results of HeartFlow FFRCT are intended to be used by qualified clinicians in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgment.
Technology
FFRCT v2.0 is coronary physiologic simulation software that analyzes CT DICOM cardiac images to assess coronary artery anatomy and function. It generates a 3D computer model to simulate blood flow, pressure, and velocity, providing combined anatomical and functional information visually and quantitatively. It is independent of imaging equipment and clinical workstations and uses physician-acquired CT data for analysis.
Performance
Clinical validation through the HeartFlowNXT prospective multicenter study demonstrated sensitivity of 84.2% and specificity of 84.9% for detection of hemodynamically-significant obstruction compared to invasive FFR measurements. The software showed superior diagnostic accuracy compared to site-read cCTA alone and was validated with stress and repeatability testing. Safety conclusions confirmed low risk given the non-invasive nature without additional imaging or radiation.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/28/2016
1 month - 2
FDA Approval
8/24/2016
Other devices from HEARTFLOW, INC.
- HeartFlow Analysis2022 • 510K
- HeartFlow Analysis2021 • 510K
- HeartFlow FFRct Analysis2019 • 510K
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