New Software OK’d for Non-Invasive FFR Estimates

The Food and Drug Administration (FDA) has approved marketing of HeartFlow FFR-CT software, a computer modeling program that allows healthcare professionals to non-invasively assess blood flow in the coronary arteries of patients with coronary artery disease.

The fractional flow reserve (FFR) value, which is used to evaluate the extent of blockage in the heart or a coronary artery, is obtained through cardiac catheterization. However, the non-invasive HeartFlow FFR-CT software allows an estimate of FFR using data from a computed tomography (CT) scan of the patient’s heart. This estimated value combined with other clinical patient data can be used to determine whether the actual FFR is below accepted limits and if it requires further FFR assessment via cardiac catheterization.

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Healthcare professionals electronically transmit the patient’s CT scan data to HeartFlow, Inc. where various 3-D computer models are created of the patient’s heart. A blood flow simulator program is run on the models and the case analyst electronically sends a report with the estimated FFR (FFR-CT) values as color images of the patient’s heart.

In clinical studies, HeartFlow FFR-CT was able to correctly detect 84% of the significant blockages identified by FFR as requiring intervention, and 86% of blockages identified by FFR as not requiring intervention.

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