Software that provides an estimate of a patient’s fractional flow reserve using data from a coronary CT scan has been cleared for marketing, the Food and Drug Administration announced Nov. 26.

The software, HeartFlow FFRCT, “is a computer modeling program that provides a functional assessment of blood flow in the coronary arteries from detailed anatomical data,” Dr. William Maisel, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in the FDA statement. He described it as a noninvasive method that “is an additional tool for clinicians who are considering the risks and benefits of invasive coronary procedures.”

The healthcare professional transmits a patient’s coronary CT scan data to the headquarters of the manufacturer, HeartFlow , where an analyst creates 3-D models of the patient’s heart and runs a blood flow simulator program on the models. The clinician is then sent a report with the estimated fractional flow reserve (FFR)-CT values “displayed as color images of the patient’s heart,” according to the FDA statement.

The FDA cleared the device based on data that compared FFR-CT measurements to those obtained with cardiac catheterization in patients with suspected coronary artery disease. The FFR-CT measurements correctly identified 84% of the significant blockages that FFR identified as requiring intervention, and 86% of blockages that FFR identified as not requiring intervention, according to the FDA.


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