FDA Allows Marketing for Heart Blood Flow Software

The FDA will allow marketing of HeartFlow FFR-CT software, which non-invasively evaluates blood flow in the coronary arteries of patients showing signs and symptoms of coronary artery disease.

The disease occurs when 1 or more major arteries on the surface of the heart become narrow or blocked, and the patient’s blood flow to the heart muscle is reduced. Typically, health care professionals use an invasive procedure called cardiac catheterization to see the extent of the blockage and obtain the fractional flow reserve (FFR) value, according to the FDA.

The HeartFlow FFR-CT software, on the other hand, provides an estimate of FFR non-invasively by using data from a computed tomography (CT) scan of the patient’s heart, according to an FDA press release. Considering other information about the patient’s health, the health care professional can then decide if a more accurate FFR measure is needed through cardiac catheterization.

The patient’s CT scans are sent to Heartflow, Inc, where a 3D computer model of the heart is created and a blood flow simulator program is run through the model. Then, a case analyst sends a report with the estimated FFR values back to the hospital, where the health care professional can view the results as color images of the patient’s heart.

A study found the software was able to correctly identify 84% of the significant blockages identified by FFR as requiring intervention and 86% of blockages identified by FFR as not requiring intervention, according to an FDA press release.