FDA Clears HeartFlow's FFR_CT Technology

December 1, 2014—HeartFlow Inc. announced that it received de novo clearance from the US Food and Drug Administration (FDA) for its mathematically computed fractional flow reserve (FFR_CT) technology, a noninvasive imaging technology for coronary artery disease that offers insight on both the extent of blockages and whether they are impacting blood flow. HeartFlow’s FFR_CT technology works by solving millions of complex equations simulating blood flow in the coronary arteries to provide the FFR_CT values from images derived using noninvasive CT angiography. 
 
According to the company, the FFR_CT platform was developed by combining noninvasive imaging with computational fluid dynamics technology to produce detailed models of a patient’s cardiovascular anatomy. The technology is cleared for the evaluation of patients showing signs and symptoms of coronary artery disease in conjunction with other clinical patient data.
 
FDA clearance of the technology was supported by clinical data from the landmark HeartFlow NXT study, which was published in April 2014 by Bjarne L. Nørgaard, MD, et al in the Journal of the American College of Cardiology (2014;63:1145–1155). 

As summarized by the company, the HeartFlow NXT study demonstrated superior discriminatory ability to identify lesions that have the potential to impede blood flow when compared to coronary CT angiography alone. In the study, FFR_CT had higher diagnostic accuracy (86%) than coronary CT angiography (65%). This difference is primarily due to a significantly increased specificity with FFR_CT (86%) compared to coronary CT angiography (60%). Invasive angiography performed with 71% accuracy in the study. 

In HeartFlow’s press release, Daniel Simon, MD, commented, “FFR_CT represents a tremendous advancement in the management of coronary artery disease. Historically, we have been faced with either using tests we knew were not always accurate or putting a patient through an invasive procedure just to determine whether they needed another invasive procedure. For the first time, we have access to a test that is both noninvasive and highly accurate in showing us the extent of a lesion, as well as how it can hinder blood flow through the vessel. I believe FFR_CT has the potential to completely change the way we manage coronary artery disease globally.” Dr. Simon is President of Harrington Heart & Vascular Institute at University Hospitals Case Medical Center, and Herman K. Hellerstein Chair and Professor of Medicine at Case Western Reserve University School of Medicine in Cleveland, Ohio.