NEWTON, Mass., Feb. 9, 2011 /PRNewswire/ — Rcadia Medical
Imaging announced today that it has received FDA 510(k) marketing
clearance for an enhanced version of its COR Analyzer® System
to assess coronary branch vessels in addition to main coronary
arteries in patients with suspected coronary artery disease (CAD).
The clearance is the third for the COR Analyzer System, a unique
clinical decision support tool that automatically detects
significant (50 percent and over) stenotic lesions in coronary
arteries from Coronary CT Angiography (cCTA) studies.
“The enhanced version expands the benefits of the COR Analyzer
System as a powerful complement to cCTA in evaluating suspected CAD
patients,” said Shai Levanon, President and CEO of Rcadia. “By
providing rapid detection of stenotic lesions our system enables
expanded use of cCTA to enhance patient care and reduce unnecessary
costs.”
The FDA clearance follows the recent publication of the first
clinical study evaluating the COR Analyzer’s enhanced version. The
study, published (online) in Academic Radiology in January
2011 by researchers at Thomas Jefferson University, demonstrated
that the “COR Analyzer provides a high negative predictive value
for the absence of coronary disease in branch vessels as well as
the major coronary arteries.”
The retrospective study, conducted by Ethan Halpern, MD, and
David Halpern, compared 207 cases evaluated by the COR Analyzer
System with expert interpretation. The final clinical
interpretation identified 48 patients with significant (over 50
percent) stenosis. The COR Analyzer System demonstrated a
sensitivity of 92 percent and a negative predictive value of 97
percent. In the study, the system’s specificity was 70 percent and
the positive predictive value was 48 percent.
The investigators noted that the “high negative predictive value
will be most useful in a population with a low prevalence of
coronary disease – such as the emergency
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