FDA Clears HeartFlow Planner Virtual Modeling Tool for CAD

Megan Brooks

September 12, 2019

The US Food and Drug Administration (FDA) has cleared the HeartFlow Planner (HeartFlow), a noninvasive virtual modeling tool for coronary artery disease (CAD) intervention, the company has announced.

The product uses an "idealized" coronary anatomy model and physiology simulation created from the HeartFlow Analysis, a color-coded 3D model of a patient's coronary arteries, the company explains in a news release.

This allows 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, the company says.

For each treatment scenario, HeartFlow Planner displays the modified CT-fractional flow reserve values in real-time to enable clinicians to understand the impact of the modeled treatment strategy. 

Common scenarios for using HeartFlow Planner include focal stenoses, serial stenoses, and borderline cases. The product is only available on iOS platforms in the United States.

"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," Mark J. Goodwin, MD, interventional cardiologist at Advocate Health Midwest Heart Specialists, Naperville, Illinois, said in the release. "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," said Goodwin.  

To date, clinicians around the world have used the product for more than 40,000 patients to aid in the diagnosis of heart disease, the company says.

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