FDA-cleared Cleerly ISCHEMIA will assist healthcare professionals in clinical diagnosis and decision making for coronary artery disease

Cleerly, the company creating a new standard of care to aid in the diagnosis of heart disease, announced that its recently U.S. Food and Drug Administration (FDA)-cleared Cleerly ISCHEMIA software device applied to a non-invasive coronary CT angiogram (CCTA) can be billed using the new Category I CPT^® code 75580. The American Medical Association (AMA) defines this service as a complementary augmented intelligence tool for noninvasive estimates of fractional flow reserve (FFR) to assist healthcare professionals in clinical diagnosis and decision making. The Category I CPT^® code is an addition to the Category III CPT^® codes (CPT^® 0623T, 0624T, 0625T, 0626T) used for reporting Cleerly’s advanced coronary atherosclerosis analysis.

Effective January 1, 2024, the AMA published updates to its CPT^® code set to include a new Category I CPT^® code 75580, described as, “Noninvasive estimate of coronary fractional flow reserve derived from augmentative software analysis of the data set from a coronary computed tomography angiography, with interpretation and report by a physician or other qualified healthcare professional.” The Cleerly ISCHEMIA software outputs an index with its “threshold equivalent to invasive FFR >0.80 vs. ≤0.80 as identified in professional societal practice guidelines.”¹

The Cleerly ISCHEMIA software outputs data that is augmentative to support clinical decision making by both the interpreting imaging physician as well as the treating physician. This analysis enables the imaging and treating physicians to interrogate each lesion across all coronary vessels in order to perform lesion-by-lesion mapping of actionable anatomic and physiologic findings of coronary artery disease in order to offer greater understanding of the pathology, and encourage the development of a personalized treatment management plan for the patient.

“The Cleerly ISCHEMIA software provides noninvasive estimates of FFR values that help healthcare professionals make critical decisions in the management of patients with suspected coronary artery disease,” said James P. Earls, MD, Chief Medical Officer of Cleerly. “Cleerly ISCHEMIA was purposely designed to output estimates of FFR values that are guideline-recommended by professional societies, and to allow comprehensive mapping of both anatomic and physiologic data for each and every coronary lesion across the entire vascular tree.”

Prior studies have demonstrated the independent and incremental benefit of Cleerly ISCHEMIA applied to CCTA beyond traditional assessment. The application of Cleerly ISCHEMIA supports improvements in physician certainty, guides medical therapy decision making, and reduces unnecessary invasive and non-invasive testing^2-6.

About Cleerly^®

Cleerly is the company on a mission to eliminate heart attacks by creating a new standard of care for heart disease. Through its FDA-cleared solutions driven by artificial intelligence, Cleerly supports comprehensive phenotyping of coronary artery disease, as determined from advanced non-invasive CT imaging. Cleerly’s approach is grounded in science, based on over 10 million images from over 40,000 patients gathered over a 15-year-period in landmark, multi-center clinical trials. Led by a world-class clinical and technical team, Cleerly enhances health literacy for each and every stakeholder in the coronary care pathway. For more information, please visit: www.cleerlyhealth.com.

1. FDA 510(k) Number K231335 Summary for Cleerly ISCHEMIA.

2. Nurmohamed NS, Danad I, Jukema R. High Diagnostic Accuracy Of AI-Ischemia in Comparison To PET, FFR-CT, SPECT, and Invasive FFR: A PACIFIC Sub-Study. Sponsored by Cleerly and Presented at the American College of Cardiology Annual Scientific Meeting New Orleans LA 2023.

3. van Rosendael A, Danad I, CREDENCE study group, PACIFIC study group. Derivation, Validation and Prognostic Assessment of an AI-Based Algorithm for Determination of Coronary Ischemia: The CREDENCE and PACIFIC Trial. in European Association of Cardiovascular Imaging: Late Breaking Clinical Research and Trials. 2023. Barcelona, Spain.

4. Chiou A, Hermel M, Miller G et al. Cleerly TM Vs. Heartflow TM vs. Site Read in The Per-Vessel Prediction of Adenosine FFR ≤0.80 With Plaque Features Associated with False Positives. Presented at the American College of Cardiology Annual Scientific Meeting New Orleans LA 2023

5. Karlsberg RP, Gonzalez Quesada C, Samuels B et al. High diagnostic accuracy of a novel artificial intelligence guided quantitative coronary computed tomography algorithm for predicting myocardial ischemia. Presented at the Society of Cardiovascular Computed Tomography Annual Scientific Meeting Boston MA 2023. Journal of Cardiovascular Computed Tomography Vol. 17 Issue 4 Supplement S28–S29 Published in issue: July, 2023.

6. Bär S, Nabeta T, Maaniitty T.. Prognostic Value of a Novel Artificial Intelligence-Based Coronary Computed Tomography Angiography-Derived Ischemia Algorithm for Patients with Suspected Coronary Artery Disease. Eur Heart J Cardiovasc Imaging. 2023 Dec 12:jead339. Epub ahead of print. PMID: 38084894.

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