Rcadia Medical Imaging has reported positive study results of its proprietary technique, designed to assess hemodynamic significance of coronary lesions from coronary CT angiography (cCTA) studies.
The retrospective study enrolled 44 patients, who underwent both cCTA and diagnostic coronary catheterisation with FFR measurements, to demonstrate the feasibility of the technique which uses cCTA studies as a non-invasive alternative to assess the hemodynamic significance of coronary lesions.
Built on the COR Analyzer System, Rcadia's proprietary technique assessed 49 of 51 lesions with FFR measurements present in the studies, while two lesions were not demonstrated due to poor image quality.
The Rcadia method correctly identified all 11 hemodynamically significant lesions (FFR <=0.8) and 33 of 38 hemodynamically insignificant lesions (FFR>0.8), yielding the sensitivity of 100% and specificity of 87%, according to the company.
Shai Levanon, Rcadia president and CEO, said determining the effect of an intermediate lesion on coronary blood flow is critical to make a treatment decision.
"Our initial study shows a good correlation to FFR, highlighting the potential of our technology to enhance the diagnostic utility of cCTA and reduce the number of invasive, costly diagnostic cardiac catheterization produces," Levanon added.
"A capability for assessing hemodynamic significance has potential to provide a powerful complement to the COR Analyzer's ability to identify significant stenosis in suspected patients with coronary artery disease."
The company's FDA-cleared product, COR Analyser System, provides fully automated, real-time analysis of cCTA and improves the utility of cCTA studies in the emergency department for triage chest pain patients, as well as optimising work flow in cardiology and radiology departments.