When doctors diagnose cancer, they typically offer a prognosis and treatment plan based on a staging system that assesses the extent and location of the cancer in the body. Similarly, staging systems exist for common chronic diseases like hypertension, type 1 and type 2 diabetes, and asthma, which depend on various factors that indicate the disease's progression. However, heart disease lacks a clinically relevant staging system for atherosclerosis, a condition that impacts millions worldwide. Now, a new four-stage system has been introduced to measure the progression of coronary artery disease (CAD) by focusing on atherosclerotic plaque which determines future heart attack risk, rather than on secondary symptoms of heart disease.

Historically, the medical approach to heart disease has revolved around surrogates (such as cholesterol), symptoms (like chest pain or breathlessness), or disease consequences (such as ischemia or stenosis). Yet, many coronary lesions causing heart attacks are not linked to these factors, often presenting silently and without causing ischemia or stenosis. Cleerly’s (Denver, CO, USA; www.cleerlyhealth.com) CAD Staging System is an innovative noninvasive imaging-based software tool designed to analyze crucial aspects of coronary atherosclerosis, stenosis, and ischemia. This system aims to provide physicians with a more precise and individualized risk assessment for patients susceptible to major adverse cardiovascular events (MACE), including heart attacks before they occur.

Cleerly’s AI-powered digital care pathway identifies and quantifies atherosclerotic plaque in arteries, revealing not just the quantity but also the type and amount of plaque. The nature of the plaque is a crucial predictor of future heart attack risk and a key indicator of a patient's impending cardiac event. Cleerly transcends traditional heart disease metrics by analyzing, characterizing, and quantifying plaque types, enabling a more accurate assessment of a patient’s heart attack risk. Cleerly’s comprehensive reports offer healthcare professionals a detailed understanding of patient risk, encompassing everything from vessel-specific details and thorough plaque analysis to stenosis scoring. This empowers physicians to convert clinical data into tailored treatment plans for each patient, regardless of the patient’s position in the heart disease spectrum and potentially saving more lives. Cleerly has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its CAD Staging System.

“As Cleerly continues to develop cardiovascular innovations to support patients and healthcare professionals, we are honored to have received Breakthrough Device Designation and join the TAP Pilot,” said James K. Min, MD, Founder and CEO of Cleerly. “This designation from the FDA highlights the critical need for better heart disease risk assessment methods. Our approach to heart disease, inspired by the most successful preventive care paradigms in medicine – including mammograms, colonoscopies, and lung CTs – enables personalized diagnosis and risk assessment and exemplifies our commitment to enhancing CAD evaluation, aiming to prevent heart attacks before they occur.”

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