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CT-Based Staging System for Coronary Artery Disease Gets FDA's Breakthrough Device Designation


Employing quantitative computed tomography, the staging system’s insights on stenosis, ischemia and coronary atherosclerosis may facilitate individualized assessments of heart disease risk.

The Food and Drug Administration (FDA) has granted Breakthrough Device Designation for Cleerly’s Coronary Artery Disease (CAD) Staging System.

Offering a four-stage approach that incorporates total plaque volume (TPV) and percent atheroma volume (PAV) assessments from quantitative computed tomography (CT), Cleerly said the CAD Staging System provides insights into actionable aspects of stenosis, ischemia, and coronary atherosclerosis.

CT-Based Staging System for Coronary Artery Disease Gets FDA’s Breakthrough Device Designation

Cleerly's Coronary Artery Disease (CAD) Staging System, which offers a four-stage approach for assessing individual heart disease risk, received Breakthrough Device Designation from the Food and Drug Administration (FDA). (Images courtesy of the Journal of Cardiovascular Computed Tomography.)

Emphasizing the system’s potential for providing individual risk assessments for heart disease, Cleerly added that a randomized controlled trial (TRANSFORM) will assess use of the CAD Staging System for patients with diabetes, pre-diabetes or metabolic syndrome who are currently asymptomatic for heart disease.

“As our Cleerly CAD Staging System becomes available to physicians and patients, it will provide the rationale for preventive tailored treatment of CAD with risk-based therapy goals,” said Udo Hoffmann, M.D., M.P.H., the chief scientific officer of Cleerly.

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