HeartFlow Analysis
HeartFlow, Inc.HeartFlow Analysis is a medical software that uses previously acquired coronary CT images to create 3D models and simulate blood flow dynamics in coronary arteries. It helps clinicians assess coronary artery disease by providing detailed functional information derived mathematically from CT scans, supporting diagnosis and treatment planning in stable symptomatic patients.
Intended Use
The HeartFlow Analysis is a coronary physiologic simulation software for clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for clinically stable symptomatic patients with coronary artery disease. It provides calculations of FFRCT, a mathematical quantity computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. It supports functional evaluation of coronary artery disease.
Technology
HeartFlow Analysis is a software medical device analyzing CT Coronary Angiography data, performing semi-automated extraction of anatomic data including heart structures, centerline detection, and providing functional simulation by computing FFRCT (Fractional Flow Reserve derived from CT). It generates 3D models of coronary arteries and derives simulated hemodynamic parameters such as blood flow and pressure for clinical use.
Performance
The device underwent design validation including stress testing, repeatability testing, and evaluation using diagnostic images from clinical trials. Preclinical studies from predicates were reviewed, concluding acceptable safety and effectiveness. The testing affirms that the device performs as intended and is safe for clinical use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
11/12/2020
1 month - 2
FDA Approval
1/8/2021
Other devices from HeartFlow, Inc.
- HeartFlow Analysis2022 • 510K
- HeartFlow FFRct Analysis2019 • 510K
- FFRct2018 • 510K
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