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The FDA has approved a novel technology that measures fractional flow reserve (FFR) noninvasively using data obtained from a computed tomographic scan of the heart. The HeartFlow FFR-CT “is a computer modeling program that provides a functional assessment of blood flow in the coronary arteries from detailed anatomical data,” said an FDA official in an agency news release.
Data from a heart CT scan are uploaded to the manufacturer’s headquarters, where they’re analyzed by the HeartFlow FFR-CT software. According to the FDA, “a case analyst creates 3D computer models of different sections of the patient’s heart and runs a blood flow simulator program on the models. After analyzing the data and the models, the case analyst electronically sends a report with the estimated FFR values … displayed as color images of the patient’s heart.”
In clinical studies, FFR-CT correctly identified 84% of lesions detected by traditional catheter-based FFR that required intervention and 86% of lesions that did not require intervention, the FDA said.