First-generation computational fluid dynamics (CFD) platforms typically model blood flow using coronary lumen geometry and estimated myocardial mass. However, vessels with identical physical caliber often display markedly different vasodilatory responses depending on the underlying biology of the vessel wall.

FFR-IQ was cleared based on results from the multicenter ELUCIDATE FFR-CT clinical trial (NCT06018194), which evaluated 491 vessels across 347 patients, directly benchmarking non-invasive FFR-IQ estimates against invasive wire-based FFR.

The clearance of FFR-IQ completes Elucid’s core product strategy: creating a unified clinical software suite that links FFR-IQ with Plaque-IQ, its FDA-cleared CT plaque analysis software.

Plaque-IQ is trained and validated against ground-truth human histopathology specimens—correlating with near-infrared spectroscopy intravascular ultrasound (NIRS-IVUS) to quantify plaque volume, evaluate stenosis, and detect high-risk features like lipid-rich necrotic cores (LRNC).

By feeding these tissue-level plaque parameters directly into FFR-IQ’s deep-learning neural network, the platform accounts for how specific plaque phenotypes alter microvascular resistance and structural vessel compliance:

Dr. Amir Ahmadi, Clinical Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai and Elucid’s lead scientific advisor, highlighted the clinical shift: “Plaque composition, coronary anatomy, and physiology are closely connected. BioIntegrated FFR-CT incorporates anatomy and plaque characteristics into the physiological estimate itself. Together with plaque assessment, this approach can help physicians evaluate the significance of an individual lesion while also addressing the patient’s broader atherosclerotic disease and need for preventive treatment.”

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