FFRct
HEARTFLOW, INC.HeartFlow FFRct is a software tool that analyzes existing CT images of coronary arteries to calculate fractional flow reserve (FFRCT). This helps clinicians assess the functional significance of coronary artery disease non-invasively, aiding diagnosis and treatment decisions without requiring additional imaging or radiation.
Intended Use
HeartFlow FFRCT is a post-processing 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.
Technology
HeartFlow FFRCT analyzes CT DICOM cardiac images using a 3D computer model to simulate pressure, velocity and blood flow generating fractional flow reserve (FFRCT). It is vendor and imaging equipment independent, performing post-processing analysis only.
Performance
HeartFlow FFRCT was validated through clinical studies comparing FFRCT results to invasive fractional flow reserve (FFR). The HeartFlowNXT study showed good sensitivity (~84%) and specificity (~85%) in detecting hemodynamically significant coronary lesions. Software was tested for repeatability, and clinical validation ensured safety and effectiveness with no adverse patient effects.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/22/2015
3 months - 2
FDA Approval
1/13/2016
Other devices from HEARTFLOW, INC.
- HeartFlow Analysis2022 • 510K
- HeartFlow Analysis2021 • 510K
- HeartFlow FFRct Analysis2019 • 510K
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