HeartFlow Secures De Novo Clearance From FDA for Imaging Technology

HeartFlow Inc. has received de novo clearance from the U.S. Food and Drug Administration for its FFR_CT technology, a non-invasive imaging technique for coronary artery disease that provides doctors with insight on both the extent of the blockage as well as its potential impact on blood flow.

The FFR_CT platform was developed by marrying non-invasive 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 our FFR_CT technology is a significant milestone that only further reinforces our belief in its potential to transform the way coronary artery disease is managed,” said John H. Stevens, M.D., chairman/CEO of HeartFlow. “Research on this technology began more than 20 years ago. We have continued to develop it with the goal of helping healthcare professionals identify the most appropriate care for each patient. We are now are a major step closer to achieving this goal.”

Coronary artery disease occurs when the arteries leading to the heart become diseased or damaged, often because of the build up of plaque in the vessel walls. The plaque—or lesions—can cut off vital blood flow to the heart, causing chest pain, heart attacks and death. Coronary artery disease affects an estimated 16.3 million U.S. adults and is one of the most costly medical conditions to the American healthcare system.

Non-invasive tests are widely used as a first-line method to diagnose coronary artery disease, but studies have shown a need to improve their accuracy. A study conducted by Duke University investigators and published in the New England Journal of Medicine found that fewer than 38 percent of patients who underwent elective invasive cardiac catheterization and angiography were found to have obstructive coronary artery lesions, even though non-invasive testing had been performed on 84 percent of those patients.¹ HeartFlow’s FFR_CT technology works by solving millions of complex equations simulating blood flow in the coronary arteries to provide mathematically computed fractional flow reserve (FFR_CT) values from images derived using non-invasive computed tomography (CT) angiography. Fractional flow reserve values demonstrate blood pressure differences around a lesion to determine whether it is likely to reduce blood flow to the heart. These simulated values help physicians determine the right course of action for each patient, company bigwigs noted.

FDA clearance of the technology was supported by clinical data from the HeartFlow NXT study that demonstrated superior discriminatory ability to identify lesions that potentially can impede blood flow when compared to coronary CT angiography alone. In the study, published in the Journal of the American College of Cardiology last year, FFR_CT had higher diagnostic accuracy (86 percent) than coronary CT angiography (65 percent). This difference is primarily due to a significantly increased specificity with FFR_CT (86 percent) compared to coronary CT angiography (60 percent).² Invasive angiography performed with 71 percent accuracy in the study.³

“FFR_CT represents a tremendous advancement in the management of coronary artery disease,” said Daniel Simon, M.D., president, 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. “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 non-invasive 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.”

Based in Redwood City, Calif., HeartFlow Inc. is a personalized medical technology company that develops non-invasive diagnoses of coronary artery disease.

References:

¹ Patel, M. et al. N Engl J Med 2010;362:886-95

² Nørgaard, B. et al. J Am Coll Cardiol 2014;63:1145–55

³ Nørgaard, B., Transcatheter Cardiovascular Therapeutics presentation, October 2013