Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 31 n° 321

Posts Tagged ‘Coronary Artery Disease’

Volcano’s Proprietary iFR® Functionality Demonstrates Excellent Results in Presentations at EuroPCR 2012

Posted by fidest press agency su martedì, 22 Mag 2012

San Diego, California, (PRNewswire) Volcano Corporation (NASDAQ: VOLC), a worldwide leader in precision guided therapy tools, today provided an overview of data from multiple ground-breaking clinical trials presented last week at the EuroPCR conference, a key international cardiology meeting held in Paris, France.
“We provide tools that allow physicians to guide procedures based on functional data, in contrast to imprecise tools such as angiogram which provide images that are not always definitive,” said Joe Burnett, Executive Vice President and General Manager of Volcano’s Functional Measurement business unit. “Physiology, and particularly Fractional Flow Reserve (FFR), has been proven to improve outcomes in powerful, well-validated clinical trials like DEFER, FAME and now FAME II, which was presented this week at EuroPCR. As a pioneer in the field, we feel very strongly that there is tremendous potential for worldwide adoption of functional assessment across many clinical indications and FFR can be made faster, simpler and more cost effective – driving more personalized care and ultimately, better outcomes for patients.”
Volcano’s Proprietary Instant Wave-Free Ratio™ (iFR®) Functionality: An Emerging Tool
Three datasets were presented for the first time at EuroPCR that expand the clinical data supporting Volcano’s proprietary Instant Wave-Free Ratio™ Functionality (iFR® Functionality). The goal of iFR® Functionality is to provide a functional, lesion-specific assessment in seconds, without injecting a vasodilator drug to induce stress on the heart. The iFR® Functionality and algorithm are being developed in a collaboration between Volcano and researchers at the Imperial College London. Volcano iFR® Functionality is under development and not approved for sale in any markets. The ADVISE Hyperemic Stenosis Resistance (HSR) Study assessed 51 lesions, calculating Volcano iFR® Functionality, FFR, and a third independent metric of lesion severity, HSR. iFR® Functionality showed the same diagnostic accuracy versus HSR (92%) as FFR versus HSR (92%). iFR® Functionality showed an Area Under the Curve (AUC) of 0.93 versus HSR, which had no statistical difference from the AUC of FFR versus HSR of 0.96 (p=0.48). The study also showed that in the 4 of 51 lesions (8%) that disagreed between Volcano iFR® Functionality and FFR, there was equal agreement with HSR. The data confirms that Volcano iFR® has comparable accuracy as FFR when both are compared to an independently validated metric of lesion severity (HSR).
An independently-conducted study presented by Dr. Jin Joo Park of Seoul National University Hospital enrolled 243 consecutive patients across 3 trial sites in Korea. Baseline pressure tracings (from which Volcano iFR® Functionality values could be derived off-line), along with FFR values using both intravenous and intracoronary adenosine, were obtained. The baseline pressure tracings were sent to a Volcano iFR® Functionality core lab at Imperial College London in blinded fashion, meaning that the core lab operators were completely blinded to the corresponding FFR values. Of 238 lesions meeting pre-specified inclusion/exclusion criteria, the Area Under the Curve was 0.89 with diagnostic accuracy of 81%. On adjustment for the intrinsic variability of FFR for this distribution, relative diagnostic accuracy was 94%. This data demonstrates for the first time an excellent correlation of Volcano iFR® Functionality and FFR in a completely blinded analysis.
New Developments in FFRAdditionally, results from the FAME II (Fractional Flow Reserve-Guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment vs. Optimal Medical Treatment Alone in Patients with Stable Coronary Artery Disease) study demonstrated clearly that patients with significant lesions identified via FFR did significantly better when stented compared with those treated with optimal medical therapy alone. This study was halted early by the independent Data and Safety Monitoring Board (DSMB) because the non-stenting (medically-treated) arm had significantly more urgent revascularizations than the FFR-guided stenting group. Data presented at EuroPCR 2012 showed an 11.2 times greater risk of urgent revascularization in the non-stenting group compared to the group that used FFR-Guided PCI.

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