FDA Approves Marketing of Cardiovascular Diagnostics Software
The U.S. Food and Drug Administration has approved marketing of software enabling clinicians to non-invasively evaluate blood flow in coronary arteries of patients showing symptoms of coronary artery disease.
The U.S. Food and Drug Administration has approved marketing of software enabling clinicians to non-invasively evaluate blood flow in coronary arteries of patients showing symptoms of coronary artery disease.
The software from Redwood City, Calif.-based from HeartFlow provides an estimate of fractional flow reserve (FFR)clinical information to help determine the extent of a blockage in the heart or a coronary arteryusing data from a computed tomography (CT) scan of the patients heart.
Housed at the companys headquarters, the HeartFlow FFR-CT software electronically receives a patients CT scan data from which a case analyst creates 3D computer models of different sections of the patients 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-CT values displayed as color images of the patients heart.
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., deputy director for science and chief scientist in the FDAs Center for Devices and Radiological Health, in a written statement. This non-invasive method is an additional tool for clinicians who are considering the risks and benefits of invasive coronary procedures.
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. Currently, FFR measured during invasive coronary angiography is the gold standard. However, the FDA review 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 software from Redwood City, Calif.-based from HeartFlow provides an estimate of fractional flow reserve (FFR)clinical information to help determine the extent of a blockage in the heart or a coronary arteryusing data from a computed tomography (CT) scan of the patients heart.
Housed at the companys headquarters, the HeartFlow FFR-CT software electronically receives a patients CT scan data from which a case analyst creates 3D computer models of different sections of the patients 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-CT values displayed as color images of the patients heart.
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., deputy director for science and chief scientist in the FDAs Center for Devices and Radiological Health, in a written statement. This non-invasive method is an additional tool for clinicians who are considering the risks and benefits of invasive coronary procedures.
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. Currently, FFR measured during invasive coronary angiography is the gold standard. However, the FDA review 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.
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