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Late-breaking Data Demonstrate AHA/ACC Guideline-directed CCTA + FFRCT Precision Pathway is Superior to Traditional Testing

Press Release

Late-breaking Data Demonstrate AHA/ACC Guideline-directed CCTA + FFRCT Precision Pathway is Superior to Traditional Testing

Using coronary computed tomography angiography (CCTA) with HeartFlow’s FFRCT Analysis to evaluate suspected coronary artery disease offers higher diagnostic accuracy, fewer unnecessary tests and higher confidence in identifying patients needing treatment.

MOUNTAIN VIEW, Calif. – November 6, 2022 — HeartFlow, Inc., the leader in revolutionizing precision heartcare, today announced new trial results that show evaluating stable chest pain patients by applying advanced artificial intelligence (AI) to CCTA increases diagnostic accuracy, reduces unnecessary testing and offers higher confidence in identifying patients needing treatment.

The results from the Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization (PRECISE) Trial were presented today as late-breaking clinical data at the American Heart Association’s (AHA) Scientific Sessions in Chicago.

“This is the strongest level of scientific evidence yet to support the approach professional guidelines recommend that physicians use to diagnose stable chest pain patients,” said Pamela Douglas, M.D., MACC, FASE, FAHA, the Ursula Geller Professor for Research in Cardiovascular Disease, Duke University School of Medicine and study chair of the PRECISE trial. “Combining multiple steps into a Precision Pathway provides a clear path forward for clinicians.”

PRECISE is the first global randomized controlled trial of its kind, enrolling 2,103 participants at 65 sites. The trial confirms that the CCTA+FFRCT-centered strategy, recognized by the AHA/ACC Guidelines, is the superior diagnostic pathway for patients with stable chest pain and suspected coronary artery disease.

The trial compares a non-invasive Precision Pathway to Traditional Testing which includes stress testing or invasive cardiac catheterization. The Precision Pathway is consistent with the AHA/ACC guideline-recognized approach that defers testing for low-risk chest pain patients and tests all others with CCTA and conditional FFRCT. FFRCT uses human analysis coupled with AI to create an interactive 3D computer model of the heart that quantifies and displays blood flow and blockages.

Compared to Traditional Testing, the PRECISE trial showed that the Precision Pathway:

  1. improved non-invasive diagnostic accuracy, significantly lowering the rates of false negatives and false positives compared to Traditional Testing in patients with coronary artery disease.
  2. reduced unnecessary tests, providing better patient experience and more efficient use of hospital resources with a 4x reduction in unnecessary invasive catheterization and necessitating fewer initial diagnostic tests overall.
  3. increased confidence in treating the right patients – 75% more likely to identify patients in need of intervention.

“We’re pleased to see these data support what the guidelines already recognize,” said Campbell Rogers, MD, FACC, Chief Medical Officer, HeartFlow. “We believe this level-one clinical science information will be used by more practitioners to guide decisions on how to optimize care for people with suspected coronary artery disease.”

A CCTA + FFRCT pathway has been adopted by more than 725 hospitals worldwide, including 80% of the Top 50 Heart Hospitals in the US.

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About HeartFlow

HeartFlow is the global leader in revolutionizing precision heart care, uniquely combining human ingenuity with advanced AI technology. Headquartered in Mountain View, California, our technology has been published in more than 500 peer-reviewed publications that showcase the value of anatomy, physiology, and plaque. We began our journey to improve coronary artery disease (CAD) diagnosis with FFRCT and have now expanded our product portfolio to include anatomic stenosis and plaque information. To date, clinicians have used our technology for more than 135,000 patients to aid in the diagnosis of heart disease.1 For more information, visit www.heartflow.com and connect on Twitter and LinkedIn.

Contact

Linly Ku
HeartFlow
media@heartflow.com

  1. Data on file at HeartFlow
cert logo hitrust.7394f2b.cda83af2e008d8cc68f55103dbde7712

The information provided by the HeartFlow Analysis is intended to be used in conjunction with the patient’s clinical history, symptoms, and other diagnostic tests, as well as the clinician’s professional judgement. The HeartFlow Analysis may not be appropriate for all patients. See indications for use for more information. The HeartFlow Analysis, featuring the FFRCT Analysis, RoadMapTM Analysis, Plaque Analysis, and HeartFlow Planner, has received FDA Clearance in the United States of America. The FFRCT Analysis and HeartFlow Planner are CE Marked in Europe and the United Kingdom and approved in Japan and Canada. The HeartFlow Analysis, featuring FFRCT Analysis, RoadMapTM Analysis, Plaque Analysis, and HeartFlow Planner, is commercially available in the United States. The FFRCT Analysis and HeartFlow Planner are commercially available in the United Kingdom. The FFRCT Analysis is also commercially available in Europe, Japan, and Canada.

© 2024 HeartFlow, Inc. | HeartFlow and the HeartFlow logo are registered trademarks of HeartFlow, Inc. Additionally, RoadMap is claimed as a trademark of HeartFlow, Inc. www.heartflow.com | 331 E Evelyn Ave, Mountain View, CA 94041

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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.