The FDA paved the way for the use of software that uses CT data to calculate fractional flow reserve (FFR) to diagnose coronary artery disease.
Using its de novo premarket review pathway, the agency cleared the way for the HeartFlow FFR-CT software, which will allow cardiologists to noninvasively assess blood flow in the coronary arteries. Physicians can send CT scan data electronically to HeartFlow, where analysts then create 3D computer models of sections of the patient’s heart and perform blood-flow simulatations to estimate FFR values. The results are displayed as color images of the patient’s heart and sent back to the ordering physician.
“This noninvasive method is an additional tool for clinicians who are considering the risks and benefits of invasive coronary procedures,” William Maisel, MD, MPH, deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said in a statement.
Redwood City, Calif.-based HeartFlow submitted safety and effectiveness findings to the FDA under a regulatory pathway for low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device. The filing included results comparing FFR-CT measurements to FFR and risk mitigation systems.