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Volcano Corp Announces Preliminary Results From ADVISE II Study


Thursday, 23 May 2013 04:30am EDT 

Volcano Corp announced preliminary results from the ADVISE (Adenosine Vasodilator Independent Stenosis Evaluation) II trial during the hot line late breaking clinical trial session at EuroPCR 2013. These prospective results confirm prior retrospective publications, and demonstrate the clinical usefulness of an iFR/Fractional Flow Reserve (FFR) Hybrid approach to simplify lesion assessment and to save the use of hyperemic drugs in a number of patients. It was also announced that this Hybrid iFR/FFR strategy, along with intravascular ultrasound (IVUS) guidance, will be used in the multi-center SYNTAX2 trial in Europe starting later this year. The ADVISE II findings replicated prior iFR retrospective publications which demonstrated that use of a Hybrid iFR/FFR workflow delivered an overall classification agreement with an FFR in more than 90% of patients participating in the trial, while saving more than 50% of such patients from hyperemic drug administration. In fact, the preliminary analysis showed 91.5% agreement with FFR and 71.5% hyperemic drug savings on a per lesion basis. Patients in ADVISE II were recruited from more than 40 centers in the United States and Europe, and all analysis was performed with operators blinded from the iFR values which were calculated offline at an independent core lab in Rotterdam, Netherlands. 

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17 Apr 2014