FFRangio System

The CathWorks FFRangio™ System offers a non-invasive method to determine the functional significance of coronary artery stenoses by generating a 3D model from standard angiograms and simulating blood flow to calculate an FFRangio™ value. Clinical studies have validated its high sensitivity and specificity in identifying hemodynamically significant lesions, positioning it as a valuable diagnostic aid for clinicians in the catheterization laboratory.

The CathWorks FFRangio™ System is a software-based medical device designed for the quantitative and qualitative analysis of coronary artery disease using previously acquired angiography DICOM data. Its primary purpose is to provide a mathematically derived fractional flow reserve value, termed FFRangio™, which is computed from simulated blood flow information based on a 3D computer model of the coronary arteries. This model is generated from standard angiographic images, with users selecting angiograms and marking key anatomical features like target lesions and vessel structures; the system then reconstructs the 3D model, enabling non-invasive functional evaluation of coronary artery disease to support clinicians in assessing coronary artery physiology. The FFRangio™ system's efficacy was established through clinical studies, notably the prospective, multicenter FAST-FFR trial, which compared FFRangio™ to invasive wire-based FFR. Results from 319 coronary lesions demonstrated high diagnostic performance, achieving a per-vessel sensitivity of 93.5% and a specificity of 91.2% (using a 0.80 FFR cutoff), thus meeting pre-specified goals. The system also showed a strong correlation (R=0.80) with invasive FFR measurements. This technology facilitates on-line FFR assessment within the catheterization laboratory using existing angiographic data, offering a non-invasive computational alternative to traditional pressure wire methods for the functional assessment of coronary lesions.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the FFRangio™ system's 3D model generation algorithm account for variations in angiographic image quality and different C-arm systems, and what is the potential impact on FFRangio™ accuracy?; What are the specific limitations or types of coronary lesions (e.g., heavily calcified, tandem lesions, diffuse disease, ostial lesions) where the accuracy of FFRangio™ might be reduced compared to invasive FFR?; Given the on-line processing capability, what is the typical turn-around time from angiogram acquisition to FFRangio™ result availability in a routine clinical catheterization laboratory setting?; How does the FFRangio™ system's performance (sensitivity, specificity, correlation) vary in specific patient subgroups, such as those with prior coronary artery bypass grafting (CABG), previous stenting in the interrogated vessel, or very small vessel diameters?; Beyond the reported sensitivity and specificity from the FAST-FFR trial, what is the detailed inter-operator and intra-operator variability of FFRangio™ measurements when performed by different clinicians using the final device configuration in diverse real-world catheterization laboratory environments?