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| Clinical Validation |
The COR Analyzer System received 510(k) approval for marketing in the U.S. based on analysis of hundreds of cCTA procedures involving all four 64 slice CTA manufacturers.
The COR Analyzer® System has been evaluated at multiple sites, which compared its findings to those reported by expert readers or to coronary angiography results. In these studies, the system demonstrated a very high per-patient sensitivity and NPV (above 95%), while generally achieving specificity above 60%. The system is currently in use at a number of leading centers in the U.S.
Recent additional studies have provided additional validation of the COR Analyzer System’s potential. For example, a study by clinicians at Beth Israel Deaconess Medical Center (Boston) presented at RSNA 2009, compared analyses of cCTA images from 115 ED patients at low to moderate risk of CAD by the COR Analyzer and two expert readers. For 100 analyzable studies, the automated results from COR Analyzer yielded a negative predictive value (NPV) of 98 percent (i.e. 98 percent of the patients determined by the COR Analyzer System to not have significant stenosis, >50 percent reduction in lumen area, were in agreement with the expert readers). The COR Analyzer System identified five of six patients determined by the expert readers to have significant stenosis, for a sensitivity of 83 percent. The specificity was 82 percent.
In a study published November 2009 on-line in European Radiology, the COR Analyzer demonstrated a 100 percent NPV on a per patient basis compared with quantitative coronary angiography. The study, which included 59 patients low to moderate risk patients who had been referred for coronary angiography, demonstrated the COR Analyzer had 100 percent sensitivity, 65 percent specificity, and 58 percent positive predictive value.
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