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FDA Clears FFR-CT System for Marketing
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The FDA announced that it has cleared for marketing a software system to compute fractional flow reserve from noninvasive CT angiography.
The FFR-CT system (HeartFlow, HeartFlow Inc.) provides health care professionals noninvasive evaluation of blood flow in the coronary arteries of patients with signs or symptoms of CAD, according to an FDA press release. The agency reviewed the system via the de novo premarket review pathway, which is for low-to-moderate-risk devices that are not substantially equivalent to an existing device.
FFR, which can determine the hemodynamic significance of lesions, is typically obtained via cardiac catheterization, but the FFR-CT software can provide an estimate without catheterization, according to the agency release.
William Maisel
“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 at the FDA’s Center for Devices and Radiological Health, stated in the release.
A health care professional sends a patient’s CT scan to the system’s software at HeartFlow Inc.’s headquarters in Redwood City, Calif., where an analyst creates 3D models of the patient’s heart and runs a blood flow simulator program. Then, a report with FFR-CT values is generated, according to the release.
The agency stated that data from clinical studies showed that the FFR-CT system was able to identify 84% of the blockages identified by FFR as needing intervention, and 86% of the blockages identified by FFR as not needing intervention.