Compliance Management

FDA Approves Non-invasive Device to Analyze Heart Blood Flow

Dec 01, 2014

The FDA allowed marketing of the HeartFlow FFR-CT software, which permits health care professionals to non-invasively evaluate blood flow in the coronary arteries of patients showing signs and symptoms of coronary artery disease.

According to an FDA press release, one piece of clinical information health care professionals use to determine the extent of a blockage in the heart or a coronary artery is a value called fractional flow reserve (FFR). Obtaining this value requires an invasive procedure called cardiac catheterization. The HeartFlow FFR-CT software can non-invasively provide an estimate of FFR using data from a computed tomography (CT) scan of the patient’s heart. The health care professional uses the estimate, along with other clinical patient data, to determine the likelihood that the actual FFR is below accepted limits and whether or not a more accurate FFR assessment using cardiac catheterization is necessary.

“HeartFlow FFR-CT is a computer modeling program that provides a functional assessment of blood flow in the coronary arteries from detailed anatomical data,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “This non-invasive method is an additional tool for clinicians who are considering the risks and benefits of invasive coronary procedures.”

The HeartFlow FFR-CT software is housed at HeartFlow, Inc.’s headquarters in Redwood City, California. A health care professional electronically sends the patient’s CT scan data to HeartFlow, Inc. where a case analyst creates 3D computer models of different sections of the patient’s heart and runs a blood flow simulator program on the models. After analyzing the data and the models, the case analyst electronically sends a report with the estimated FFR values (called FFR-CT values) displayed as color images of the patient’s heart.

Read the full release