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Trial Demonstrates HeartFlow FFRCT Analysis Significantly Lowers Cost of Care,
Improves Quality of Life for Coronary Artery Disease
Up to 32% reduction in cost when using FFRCT-guided treatment strategy compared to invasive
coronary angiography
SAN FRANCISCO - Oct. 13, 2015 - New data shows that technology developed by HeartFlow, Inc.
could lower the cost of evaluating patients with suspected coronary artery disease by as much as 32
percent. The late-breaking data, presented at the annual Transcatheter Cardiovascular Therapeutics
(TCT) meeting and simultaneously published in the Journal of the American College of Cardiology,
also demonstrates the potential for use of the HeartFlow® FFRCT Analysis to improve patient quality of
life.
The findings were part of the multicenter, controlled, prospective PLATFORM (Prospective
Longitudinal Trial of FFRCT: Outcome and Resource Impacts) trial, which included more than 580
patients. The study compared standard diagnostic strategies to the company’s HeartFlow Analysis, the
only non-invasive technology to offer physicians insight into both the extent of a patient’s arterial
blockage and the impact the blockage has on blood flow.
Studies have shown the need to improve the accuracy of non-invasive tests used to evaluate coronary
artery disease. A recent study, which included data from more than 1,100 U.S. hospitals, found that 55
percent of the more than 385,000 patients with stable chest pain who underwent an invasive coronary
angiogram had no obstructive coronary disease.1
“Non-invasive coronary angiography with cardiac CT is very sensitive in detecting
anatomic abnormalities, but does not evaluate whether the lesion seen by CT is actually impeding
coronary blood flow,” said lead investigator Mark A. Hlatky, M.D., Stanford University School of
Medicine. “Our study suggests that the information about the effects of lesions on blood flow that is
provided by FFRCT could reduce the use of invasive coronary angiography, and thereby reduce costs,
in patients who otherwise would have been scheduled for invasive procedures.”
In the PLATFORM trial, patients were divided into one of two groups - those with a planned invasive
test and those with a planned non-invasive test. Patients in each group were then enrolled into one of
two sequential cohorts - those who followed the usual diagnostic path and those who received the
FFRCT-guided strategy. Cumulative medical costs for all patients were measured over 90 days using
the 2015 Medicare reimbursement rates and online pharmacy costs as the standard in order to
provide an accurate cost comparison.
In patients with a planned invasive test, the 90-day, per-patient cost of medical care was 32 percent
lower in the FFRCT-guided strategy than in the usual care strategy ($7,343 vs. $10,734, p<0.0001).
The savings did not account for the cost of FFRCT because Medicare has not set a reimbursement rate
for the technology. However, the authors concluded that use of FFRCT guided evaluation could be cost
saving compared with invasive testing under most likely levels of reimbursement for FFRCT. For
example, they calculated that if reimbursement for the HeartFlow Analysis were $2,100, use of the test
would still save the healthcare system 20 percent over an invasive usual care strategy.
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In addition to the cost savings, FFRCT showed greater improvement in quality of life at 90-day follow-
up, as compared to baseline, than evaluation with usual non-invasive testing.
“We developed FFRCT with the goal of not only improving clinical care and patient outcomes, but also
driving down costs by helping to ensure that invasive procedures were reserved only for the patients
who needed them,” said John H. Stevens, M.D., chairman and CEO of HeartFlow. “It is gratifying to
see the promise of our technology repeatedly validated through clinical trials.”
The health economics and quality of life data follow initial PLATFORM study results presented at the
European Society of Cardiology in September and simultaneously published in the European Heart
Journal.2 The first set of data focused on the clinical impact of FFRCT.
The FFRCT platform was developed by combining computational fluid dynamics, image processing and
big data technology to produce detailed models of a patient’s cardiovascular anatomy and blood flow.
FFRCT technology solves millions of complex equations simulating blood flow in the coronary arteries
to provide mathematically computed fractional flow reserve values from images derived from non-
invasive coronary CT Angiography (cCTA). FFRCT values indicate blood pressure differences around a
coronary narrowing to determine whether it is likely to reduce blood flow to the heart.
The HeartFlow FFRCT Analysis has been evaluated in four large, prospective clinical trials enrolling a
total of more than 1,100 patients at major medical centers worldwide. It received CE mark in 2011 and
U.S. Food and Drug Administration clearance in November 2014.
About PLATFORM
PLATFORM is a multicenter, controlled, prospective, pragmatic, comparative effectiveness trial
utilizing a consecutive cohort design. It included 584 patients with stable chest pain at 11 centers
across Europe. The study evaluated the effectiveness of usual care testing, which was decided by the
site, to testing utilizing cCTA and, when necessary, FFRCT. Patients were divided into one of two
groups - those with a planned invasive test and those with a planned noninvasive test. Patients in
each group were then enrolled into one of two sequential cohorts - those who followed the usual
diagnostic path and those who received the FFRCT-guided strategy.
Enrollment was completed in November 2014. Results released today reflect all patients being
followed for a minimum of 90 days. Subsequent follow up to one year is ongoing.
About HeartFlow Inc.
HeartFlow Inc. is a personalized medical technology company seeking to transform the way
cardiovascular disease is diagnosed and treated. The company’s HeartFlow Analysis is the first
available non-invasive solution that enables a physician to more accurately evaluate whether a patient
has significant coronary artery disease (CAD) based on both anatomy and physiology. The novel
solution, which produces a model of the patient’s coronary arteries, is well positioned to become an
integral part of the standard of care for patients who are at risk for CAD because of its potential to
improve clinical outcomes, improve the patient experience and reduce the cost of care. The HeartFlow
Analysis is commercially available in the United States, Europe and Japan. For more information visit
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1 Patel, M. et. al. Am Heart J 2014;167:846-852
2 Douglas, P. et. al. Eur Heart J. 2015 (doi:10.1093/eurheartj/ehv444)
Media Contact:
Diana Soltesz
Nobles Global Communications
818-618-5634
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