HeartFlow Planner Receives FDA Clearance

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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.”

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