HeartFlow Planner Approved by FDA

HeartFlow Planner Photo, Courtesy of HeartFlow

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California-based HeartFlow has developed a real-time 3D modeling tool for interventional cardiology that recently passed clearance from the FDA. Known as the HeartFlow Planner, this tool will allow cardiologists to develop a treatment strategy for patients who require surgery for coronary artery disease (CAD). Each patients’ coronary arteries are modelled through 3D color-coded imagery where blockages can be discovered and the appropriate treatment can be determined.

During a press release, HeartFlow President and Chief Executive Officer Dana G. Mead, Jr. said that “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” and that they “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.”

iData Research’s extensive market analysis has found that procedure growth is exhibiting a positive effect on the associated device markets, such as stents, balloon catheters, interventional catheters and guidewires and various other devices required per procedure. Angiography procedure volume is also expected to remain stable over the forecast period. One of the factors driving procedure growth is the development of specialized devices and treatment techniques for patients that would otherwise be treated with coronary artery bypass graft (CABG) or be medically managed. Procedural growth may benefit the HeartFlow planner as it will increase the demand for new technologies in interventional cardiology.

The HeartFlow Planner helps physicians plan for each surgery in real time, while understanding the impact of each treatment strategy. Cardiac Innovations & Structural Heart Center®, Edward-Elmhurst Health stated that the “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.”



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