HeartFlow Seeks FDA Clearance for Next-Generation Technology for the FFR CT Analysis

December 13, 2021—HeartFlow, Inc. announced that it has submitted a 510(k) premarket application to the FDA to add advanced anatomic assessment and plaque evaluation to the HeartFlow fractional flow reserve computed tomography (FFR_CT)analysis.

According to the company, the PreRead anatomic assessment technology will help identify the presence and location of stenoses in the coronary arteries based on coronary CT scans. The HeartFlow plaque technology will provide plaque volume and characterize the type of plaque present.

The HeartFlow FFR_CT analysis is commercially available in the United States, United Kingdom, Canada, Europe, and Japan, advised the company.

By adding the anatomic assessment and plaque evaluation to the physiological information currently provided by the HeartFlow analysis, physicians will gain a more comprehensive understanding of patients’ coronary disease burden and support efficient risk stratification of patients who may be at high risk of death from a heart attack, stated the company.

PreRead is designed to provide a rich anatomic assessment of each coronary CT, that, when considered by physicians in conjunction with other patient clinical information, helps physicians to quickly identify where coronary disease is present and understand the severity of the narrowing.

The assessment highlights areas of modeled stenosis > 30% for vessels with diameters ≥ 1.8 mm. This information will be provided as a two-dimensional image of the coronary arteries, with areas of concern color coded by severity. In addition, CT images of each of the three main arteries are provided so physicians can more easily confirm the PreRead color-coded narrowings, stated HeartFlow.