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HeartFlow Secures De Novo Clearance from the U.S. Food and Drug Administration for
Breakthrough FFRCT Technology
Highly Accurate, Non-invasive Test Has the Potential to Change the
Way Coronary Artery Disease is Managed
REDWOOD CITY, Calif. - Dec. 1, 2014 - HeartFlow Inc., a pioneer in personalized medical
technology for cardiovascular disease, today announced that it received de novo clearance from
the U.S. Food and Drug Administration for its FFRCT technology. HeartFlow FFRCT is the first
and only non-invasive imaging technology for coronary artery disease to offer insight on both
the extent of the blockage, as well as whether it is impacting blood flow, two vital pieces of
information physicians need to develop a treatment plan that is right for a patient.
The FFRCT 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 conjuntion with other clinical patient data.
“FDA clearance of our FFRCT 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 and 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 precisely, safely, efficiently and
cost-effectively. We are now are a major step closer to achieving this paramount goal.”
Coronary artery disease develops 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 adults and is one of the most costly medical
conditions to the United States 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 FFRCT technology works by solving millions of complex equations simulating blood
flow in the coronary arteries to provide mathematically computed fractional flow reserve (FFRCT)
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.
FDA clearance of the technology was supported by clinical data from the landmark HeartFlow
NXT study that 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,
published in the Journal of the American College of Cardiology earlier this year, FFRCT had
higher diagnostic accuracy (86 percent) than coronary CT angiography (65 percent). This
difference is primarily due to a significantly increased specificity with FFRCT (86 percent)
compared to coronary CT angiography (60 percent).2 Invasive angiography performed with 71
percent accuracy in the study.3
“FFRCT represents a tremendous advancement in the management of coronary artery disease,”
said Dr. Daniel Simon, 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 FFRCT has the
potential to completely change the way we manage coronary artery disease globally.”
About HeartFlow Inc.
HeartFlow Inc. is a personalized medical technology company dedicated to transforming the
way cardiovascular disease is managed. Committed to improving outcomes, reducing costs and
creating a better patient experience, HeartFlow’s goal is to provide healthcare professionals with
actionable knowledge about each patient by combining best-in-class, non-invasive healthcare
imaging with advanced, computational fluid dynamics technology and the insights of big data.
HeartFlow’s non-invasive FFRCT technology helps physicians diagnose coronary artery disease
and provides them with information they need to manage each patient. For more information
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Media Contact:
Diana Soltesz
Nobles Global Communications
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!