FDA www.fda.gov has approved the marketing of the HeartFlow FFR-CT software permitting healthcare professionals to non-invasively evaluate blood flow in the coronary arteries of patients that show signs and symptoms of coronary artery disease (CAD).
CAD occurs when one or more of the major arteries on the surface of the heart becomes narrow or blocked causing blood flow to be reduced. One piece of clinical information needed to determine the extent of a blockage in the heart or a coronary artery is to determine the Fractional Flow Reserve (FFR).
Obtaining the FFR requires an invasive procedure called cardiac catheterization. The HeartFlow FFR-CT software can non-invasively provide an estimate of FFR using data from a computed tomography (CT) scan of the patient’s heart.
The healthcare professional uses the estimate along with other clinical patient data to determine the likelihood that the actual FFR is below accepted limits and whether or not a more accurate FFR assessment using cardiac catheterization is necessary.
The HeartFlow FFR-CT software is housed at the company’s headquarters in Redwood City, California http://heartflow.com. A healthcare professional electronically sends the patient’s CT scan data to the company where a case analyst creates 3D computer models on different sections of the patient’s heart.
Then the case analyst runs a blood flow simulator program on the models. After analyzing the data and the models, the analyst electronically sends a report with the estimated FFR values displayed as color images of the patient’s heart.
To have the software approved, the company submitted data to FDA on clinical studies that compared FFR-CT measurements to FFR values directly measured by cardiac catheterization on subjects with suspected coronary artery disease who were referred for catheterization and FFR.
The results showed that the software was able to correctly identify 84 percent of the significant blockages identified by FFR as requiring intervention and 86 percent of blockages identified by FFR as not requiring intervention. The company also submitted data showing how they have mitigated risks associated with the device such as controlling for erroneous calculations that can lead to delayed or improper treatment.
FDA reviewed the data for the device through the de novo premarket review pathway, a regulatory pathway for some low-to-moderate risk medical devices that are not substantially equivalent to an already legally marketed device.