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HeartFlow Receives FDA 510(k) Clearance for its Plaque Analysis and RoadMap™ Analysis

Press Release

HeartFlow Receives FDA 510(k) Clearance for its Plaque Analysis and RoadMap™ Analysis

HeartFlow is the first and only company to provide non-invasive anatomy, physiology, and plaque information based on coronary computed tomography angiography (CCTA).

MOUNTAIN VIEW, Calif. – October 18, 2022 — HeartFlow, Inc., the leader in revolutionizing precision heart care, has received U.S. Food and Drug Administration(FDA) 510 (k) clearance on two new, AI-powered products: Plaque analysis and RoadMap analysis. With its expanded product portfolio, HeartFlow is the first and only company to provide non-invasive coronary artery anatomy (RoadMap analysis), physiology (HeartFlow® FFRCT), and plaque information (Plaque analysis) based on CCTA. These products enable physicians to gain a more comprehensive understanding of a patient’s coronary artery disease (CAD) and are the most accurate approach to predict risk of a heart attack.1

“The 510(k) clearance of our Plaque and RoadMap analyses represents a major milestone in the company’s commitment to provide physicians with richer clinical insights to help diagnose and treat individual patients, no matter where they are on the coronary disease spectrum,” said John Farquhar, President and Chief Executive Officer, HeartFlow. “FFRCT has already been recognized by the recent ACC/AHA Chest Pain Guidelines and is poised to change the standard-of-care in patients. Plaque and RoadMap analyses, together with FFRCT, establish HeartFlow’s platform technologies and will enable further development of AI-powered risk scoring to better identify asymptomatic patients at risk of heart attack.”

HeartFlow’s Plaque analysis has been studied in 11,000+ patients and will provide physicians with comprehensive and actionable data showing plaque characteristics and volume in all major coronary arteries.2 It enables critical information regarding coronary plaque to be delivered conveniently to physicians along with anatomy and physiology.3 Centers for Medicare & Medicaid Services recently announced that, as of October 1, 2022, the plaque analysis is paid as a separate service in the hospital outpatient department.

The RoadMap analysis will enable CT readers to improve CAD diagnosis by providing visualization and quantification of the location and severity of anatomic narrowings in the coronary arteries on every CCTA. It has been shown to provide reproducible results and can help enable efficient, standardized, and high quality CT interpretation.4

“It is exciting to note the work HeartFlow is doing to bring forward the innovative technologies to help us advance our understanding and care for patients with coronary artery disease. Combining anatomy, physiology, and plaque morphology would be essential for personalized patient care,” said Jagat Narula, MD, PhD, Chief of Cardiology at Mount Sinai Morningside Hospital.

With this FDA 510(k) clearance, HeartFlow will begin real-world clinical use of the Plaque and RoadMap analyses with select hospitals and health systems. HeartFlow’s latest technologies will play a vital role in improving cardiovascular patient care.

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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.5 For more information, visit www.heartflow.com and connect on Twitter and LinkedIn.

Contact

Linly Ku
HeartFlow
media@heartflow.com

  1. Emerald I – Lee, et al. JACC Imaging 2019. doi.org/10.1016/j.jcmg.2018.01.023
  2. HeartFlow NOMOGRAM Data. Presented at SCCT July 2022
  3. Williams, et al. Circulation 2020. Low-Attenuation Noncalcified Plaque on Coronary Computed Tomography Angiography Predicts Myocardial Infarction.
  4. Khasanova, et al. JCCT 2022. https://doi.org/10.1016/j.jcct.2022.04.005
  5. Data on file at HeartFlow
cert logo hitrust.7394f2b.cda83af2e008d8cc68f55103dbde7712

HeartFlow Analysis is consisted of four main functions; FFRCT, Planner, Roadmap, and Plaque. All four functions are cleared for clinical use in the United States, Bahrain, Israel, and United Arab Emirates. Only FFRCT and Planner functions are cleared cleared for clinical use in Europe, United Kingdom, Australia, Canada, and Japan. Please see HeartFlow Analysis Indications for Use and Instructions for Use for more information.

© 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.