ADVISE Study Results Demonstrate the Instant Wave-Free Ratio™, a Vasodilator-Free Measure of Stenosis Severity, is Compara... ( an international multi-center study ass...)

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ADVISE Study Results Demonstrate the Instant Wave-Free Ratio™, a Vasodilator-Free Measure of Stenosis Severity, is Comparable to FFR

Date:11/14/2011

, an international multi-center study, assessed 157 stenoses in 131 patients to validate the iFR technology. Wave intensity analysis identified a wave-free period during which intracoronary resistance at rest is similar in variability and magnitude (CV:0.08+0.06 and 284+147mmHg.s/m) to that during FFR (CV:0.08+0.06 and 302+315mmHg.s/m, p=NS for both). The resting distal to proximal pressure ratio during this period, the iFR, correlated closely with FFR (r=0.9, p<0.001) with excellent diagnostic efficiency (receiver operating characteristic area under curve of 93%, at FFR<0.8), specificity, sensitivity, negative and positive predictive values of 91%, 85%, 85% and 91%, respectively. Overall diagnostic accuracy was 88%.

"The instant wave-Free Ratio (iFR) is calculated during a period in the cardiac cycle when intra-coronary resistance is naturally constant and minimized, similar to what is achieved during hyperemia with vasodilators such as adenosine over the entire cardiac cycle. We call this the 'wave-free period,' as forward- and backward-traveling wave activity has ceased," said Dr. Davies.

"In an environment where decision-making in the cath lab is increasingly questioned, Volcano is committed to delivering tools that give physicians what we call the 'moment of proof': a quantifiable measure of lesion severity that is more precise than angiography and justifies the use of a stent based on each patient's individual physiology," said Joe Burnett, EVP and General Manager of Functional Management for Volcano.

"The FAME study investigators did a tremendous job building the evidence required to move the FFR guidelines and drive physician adoption worldwide and we believe we still have plenty of opportunity ahead to improve the technology and to access more patients," said Scott Huennekens, President and CEO of Volcano. "Volcano and our partners at Imperial College London share a goal of driving the next wave of iFR
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