Press Release

HeartFlow Announces FDA Clearance for HeartFlow Planner

New interactive tool allows interventional cardiologists to model treatment strategies in real time before entering the catheterization lab

REDWOOD CITY, Calif. – September 12, 2019 – HeartFlow, Inc. today announced that it has obtained clearance from the U.S. Food and Drug Administration (FDA) for the HeartFlow Planner, a non-invasive, real-time virtual modeling tool for coronary artery disease (CAD) intervention. The HeartFlow Planner will enable interventional cardiologists to virtually model clinical scenarios vessel-by-vessel, explore treatment strategies for patients with CAD before each procedure, review cases with colleagues, and ensure everyone has a clear picture of the initial treatment plan.

“With the HeartFlow Planner, I am able to run multiple treatment scenarios in my office prior to the procedure which enables me to plan ahead about the resources I will need in the catheterization lab,” said Dr. Mark J. Goodwin, interventional cardiologist, Advocate Health Midwest Heart Specialists and system director, Cardiac Innovations & Structural Heart Center®, Edward-Elmhurst Health. “HeartFlow Planner is an intuitive consulting tool I can use to discuss cases with the entire heart team to ensure the team is prepared and engaged.”

“The information provided by the HeartFlow technology is powerful and will not only help us efficiently diagnose coronary artery disease but help us better understand different treatment options,” said Dr. Victor Marinescu, cardiologist, Advocate Health Midwest Heart Specialists and member of the medical staff, Edward-Elmhurst Health. “The visual nature of the HeartFlow Planner also makes it a great tool to explain to patients what will happen during their procedure.”

The HeartFlow Planner is a pre-procedure planning tool that is based on an idealized model of the HeartFlow Analysis, a color-coded 3D model of a patient’s coronary arteries. Physicians can use this model to identify blockages and explore multiple treatment scenarios by virtually modifying the vessel. HeartFlow Planner will enable physicians to understand the impact of each modeled treatment strategy in real time.

“As part of the company’s commitment to improve the standard of care for patients with coronary artery disease, the FDA clearance of HeartFlow Planner represents a major milestone in ensuring more physicians have access to our innovative healthcare solution,” said Dana G. Mead, Jr., President and Chief Executive Officer, HeartFlow. “We look forward to introducing the HeartFlow Planner to the interventional cardiology community and continuing to change the way coronary artery disease is diagnosed and treated.”

HeartFlow will be showcasing the HeartFlow Planner at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting taking place in San Francisco, September 25-29, Booth # 2343.

About the HeartFlow FFRCT Analysis and HeartFlow Planner

Data from a patient’s non-invasive coronary computed tomography angiogram (CTA) are securely uploaded from the hospital’s system to HeartFlow’s software application running in the AWS cloud. HeartFlow leverages deep learning and highly trained analysts to create a personalized, digital 3D model of the patient’s coronary arteries. The HeartFlow Analysis then uses powerful computer algorithms to solve millions of complex equations to simulate blood flow and assess the impact of blockages on coronary blood flow. The HeartFlow Analysis is provided via a secure online interface to offer actionable information to enable clinicians to determine the optimal course of treatment. To date, clinicians around the world have used the HeartFlow Analysis for more than 40,000 patients to aid in the diagnosis of heart disease.

The HeartFlow Planner utilizes an idealized coronary anatomy model and physiology simulation created from the HeartFlow Analysis. Physicians are able to identify stenoses and virtually modify the vessel. For each treatment scenario, HeartFlow Planner will display the modified FFRCT values in real time to enable physicians to understand the impact of the modeled treatment strategy. Common scenarios for using HeartFlow Planner include focal stenoses, serial stenoses, and borderline cases. HeartFlow Planner is only available on iOS platforms in the United States.

About HeartFlow, Inc.

HeartFlow, Inc. is a digital health company uniquely positioned at the intersection of advanced artificial intelligence and healthcare to transform how heart disease is diagnosed and treated. Our non-invasive HeartFlow FFRCT Analysis leverages deep learning to create a personalized 3D model of the heart. By using this model, clinicians can better evaluate the impact a blockage has on blood flow and determine the best treatment for patients. Our technology is reflective of our Silicon Valley roots and incorporates decades of scientific evidence with the latest advances in artificial intelligence. The HeartFlow FFRCT Analysis is commercially available in the United States, Canada, Europe and Japan. The HeartFlow Planner is commercially available in the United States only. For more information, visit www.heartflow.com.


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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.