Elucid has announced US Food and Drug Administration (FDA) 510(k) clearance of FFR-IQ, its software for non-invasive estimation of fractional flow reserve (FFR) from coronary CT angiography (FFR-CT).
FFR-IQ introduces BioIntegrated FFR-CT, which incorporates coronary anatomy and plaque composition into the estimation of coronary physiology to support more accurate individualised assessment and more precise treatment decisions, the company says in a press release.
Invasive FFR indicates whether a narrowing in a coronary artery is limiting blood flow to the heart muscle and has traditionally been measured with an invasive pressure wire during cardiac catheterisation as the gold standard to determine whether revascularisation, such as coronary artery stent or bypass, is needed. By estimating FFR non-invasively, FFR-IQ can help physicians identify which patients are likely to benefit from invasive evaluation and treatment, potentially helping avoid the majority of unnecessary catheterisations while identifying flow-limiting disease requiring revascularisation that anatomy alone may miss, Elucid’s press release states.
“Plaque composition, coronary anatomy, and physiology are closely connected,” said Amir Ahmadi (Icahn School of Medicine at Mount Sinai, New York, USA), Elucid’s lead scientific advisor, stated. “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.”
“Physicians have told us they want a more accurate FFR-CT, and we’re thrilled to deliver on that need with the most accurate,” said Kelly Huang, CEO of Elucid. “Elucid’s mission is predicting and personalising the prevention of heart attacks and strokes, and our high-performing FFR-IQ, alongside Plaque-IQ, is intended to be a step change for current patient care and a step forward to the future of personalised medicine in cardiology.”
The ELUCIDATE FFR-CT study, which supported Elucid’s recent US FDA 510(k) clearance of FFR-IQ, demonstrated an overall sensitivity of 92.2% and specificity of 93.1%, the highest of any FFR-CT validation study.
Results of the study, which detail the diagnostic performance of Elucid’s BioIntegrated FFR-IQ product, will be presented at the upcoming Transcatheter Cardiovascular Therapeutics (TCT) conference (31 October–1 November, San Diego, USA).
