Summary: Elucid’s PlaqueIQ software, now FDA-cleared, provides non-invasive plaque analysis using histology to help physicians assess cardiovascular disease risk, identify high-risk plaques, and plan treatments more precisely.

Key Takeaways

  • PlaqueIQ has been approved by the FDA as a non-invasive tool to quantify and classify plaque morphology using histology for cardiovascular disease diagnosis.
  • The software uses coronary CT angiography to identify high-risk plaque components, supporting earlier detection and management of heart disease risks.
  • PlaqueIQ enables physicians to move beyond risk estimation by providing direct visualization of plaque, improving decisions about treatment and interventions.

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Elucid’s PlaqueIQ software has received 510(k) clearance from the U.S. FDA for use in diagnosing cardiovascular disease. It is the first non-invasive tool to quantify and classify plaque morphology based on histology, supporting physicians in patient risk assessment and treatment planning.

Plaque Buildup Fuels Heart Attacks and Strokes

Cardiovascular disease is the leading cause of death and disability worldwide, driven by myocardial infarction and ischemic stroke caused by plaque buildup and rupture. Although risk factors like age, diet, and lifestyle play a role, the type and quantity of plaque are the strongest predictors of future events. Approximately half of Americans aged 45 to 84 have atherosclerosis, often without knowing it.

“Asymptomatic, low-risk patients make up a large portion of the population, but even a small fraction of these cases can result in a significant number of myocardial infarctions,” says Amir Ahmadi, clinical associate professor of medicine and cardiology at the Icahn School of Medicine, and co-director of the Cardiac Intensive Care Unit at Mount Sinai Fuster Heart Hospital in New York City. “We need to move beyond estimating risk and focus on visualizing and managing the disease in coronary arteries. PlaqueIQ helps us better quantify plaque types and improve precision in patient care.”

The software uses coronary CT angiography to generate detailed, interactive reports that provide physicians with vessel-level plaque visualization. Leveraging histology, it non-invasively identifies and quantifies components like lipid-rich necrotic core, which are associated with higher risks of heart attack and stroke. This information enables earlier identification of high-risk plaques, potentially preventing major events.

Imaging Offers New Coronary Insights

“Histology-based plaque analysis represents a new approach in non-invasive coronary imaging,” says Mark Rabbat, MD, professor of medicine and radiology at Loyola University Chicago. “With insights into vulnerable plaque components, we can make better decisions regarding drug therapy or whether a patient needs catheterization.”

Physicians can upload patient images to Elucid’s platform for analysis. The software applies motion and artifact correction, segments the data, and creates 3D models of the coronary arteries to identify, classify, and quantify plaque.

Elucid plans to release PlaqueIQ in limited availability in late 2024 and is also seeking approval for an additional application to non-invasively measure fractional flow reserve, which assesses coronary blockages and ischemia severity.