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FDA News Release

FDA allows marketing of non-invasive device to help evaluate heart blood flow

For Immediate Release

November 26, 2014


The U.S. Food and Drug Administration today 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.  

Coronary artery disease, also called coronary heart disease, is the leading cause of death for both men and women in the United States. It occurs when one or more of the major arteries on the surface of the heart become narrow or blocked, reducing blood flow that supplies the heart muscle with oxygen-rich blood. Coronary artery disease can lead to chest pain (angina), heart attack, heart failure and death.  

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.  

The FDA reviewed the data for HeartFlow FFR-CT through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.

Data submitted to support the safety and effectiveness of HeartFlow FFR-CT included clinical studies that compared FFR-CT measurements to FFR values directly measured by cardiac catheterization on subjects with suspected coronary artery disease who were therefore referred for catheterization and FFR. The results showed that Heart Flow FFR-CT was able to correctly identify 84 percent of the significant blockages identified by FFR as requiring intervention, and 86 percent of blockages identified by FFR as not requiring intervention. The company also submitted data and information showing how they have mitigated risks associated with the device, such as controlling for erroneous calculations that can lead to delayed or improper treatment.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


Page Last Updated: 11/26/2014
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