HeartFlow said yesterday that it won FDA clearance for its Planner tool for coronary artery disease intervention.
The Redwood City, Calif.-based company developed FFRct, which works by taking the data from a standard CT scan and applying algorithms that result in a color-coded 3D “map” detailing changes in flow across coronary lesions.
The Planner virtual modeling tool is designed to create a color-coded 3D model of a patient’s coronary arteries, allowing physicians to identify blockages and explore multiple treatment scenarios by virtually modifying the vessels. A commercial rollout is slated for the annual Transcatheter Cardiovascular Therapeutics meeting in San Francisco Sept. 25-29, HeartFlow said.
“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,” president & CEO Dana Mead Jr. said in prepared remarks. “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.”
“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,” added Dr. Mark Goodwin, of Edward-Elmhurst Health in Illinois. “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.”