Press Release

PLATFORM Trial Shows HeartFlow FFRCT Analysis Significantly Decreases Unnecessary Invasive Diagnostic Testing for Coronary Artery Disease

83% reduction in invasive tests showing no obstructive disease; revascularization rates unchanged

LONDON – Sept. 1, 2015 – A technology developed by HeartFlow, Inc. has been shown to significantly reduce the use of invasive catheterization in patients with suspected coronary artery disease, according to a study presented today in a “Hot Line” session at the European Society of Cardiology annual scientific meeting in London. Led by Duke University School of Medicine researchers, the study compared standard diagnostic strategies to the HeartFlow® FFRCT Analysis, the only non-invasive technology available to offer physicians insight into both the extent of a patient’s arterial blockage and the impact the blockage has on blood flow.

The multicenter, controlled, prospective PLATFORM (Prospective LongitudinAl Trial of FFRCT: Outcome and Resource IMpacts) trial, which was simultaneously published in the European Heart Journal, included more than 580 patients and demonstrated the following:

“The study demonstrated that by using FFRCT, physicians were able to efficiently triage patients to the most appropriate care and dramatically reduce the use of invasive testing, which comes with greater risk and higher costs,” said lead investigator Pamela Douglas, M.D., the Ursula Geller Professor at the Duke Clinical Research Institute, Duke University School of Medicine. “While FFRCT is a relatively new technology, this study shows that physicians and patients being evaluated for stable chest pain should consider including this new test in the course of standard diagnostics.”

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.

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 suspected coronary artery disease who underwent an ICA had no obstructive coronary disease.1

“After three major validation studies comparing the HeartFlow Analysis to invasive FFR, PLATFORM is the first prospective trial designed to demonstrate the impact of the technology in real world practice,” said John H. Stevens, M.D., chairman and CEO of HeartFlow. “The striking results of PLATFORM indicate that the HeartFlow Analysis could represent a fundamental shift in the management of coronary artery disease.”

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 observational 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 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.

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 www.heartflow.com.


  1. Patel, et al., Am Heart J 2014 Jun; 167(6): 846-52.

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HeartFlow FFRCT 分析は、有資格の臨床医による臨床的に安定した症状のある冠状動脈疾患患者への使用を目的とした個別化された心臓検査です。 HeartFlow Analysis によって提供される情報は、資格のある臨床医が患者の病歴、症状、その他の診断検査、および臨床医の専門的判断と組み合わせて使用​​することを目的としています。

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The HeartFlow FFRCT Analysis is a personalized cardiac test indicated for use in clinically stable symptomatic patients with coronary artery disease by qualified clinicians. The information provided by the HeartFlow Analysis is intended to be used by qualified clinicians in conjunction with the patient’s history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgement.

For additional indication information about the HeartFlow Analysis, please visit www.heartflow.com/indications.

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Campbell Rogers, M.D., F.A.C.C.

Executive Vice President and Chief Medical Officer

Campbell brings a wealth of experience to HeartFlow, where he serves as the Chief Medical Officer. Prior to joining HeartFlow, he was the Chief Scientific Officer and Global Head of Research and Development at Cordis Corporation, Johnson & Johnson, where he was responsible for leading investments and research in cardiovascular devices. Prior to Cordis, he was Associate Professor of Medicine at Harvard Medical School and the Harvard-M.I.T. Division of Health Sciences and Technology, and Director of the Cardiac Catheterization and Experimental Cardiovascular Interventional Laboratories at Brigham and Women’s Hospital. He served as Principal Investigator for numerous interventional cardiology device, diagnostic, and pharmacology trials, is the author of numerous journal articles, chapters, and books in the area of coronary artery and other cardiovascular diseases, and was the recipient of research grant awards from the NIH and AHA.

He received his A.B. from Harvard College and his M.D. from Harvard Medical School.