SAN DIEGO and PARIS, May 23, 2013 /PRNewswire/ — Volcano Corporation (NASDAQ: VOLC), a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, today 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 significant 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.
“An important step in the validation of any new technology is to identify a hypothesis based on observations, and to then prospectively test the hypothesis in a large number of centers to see if the observations translate to real-world practice,” commented Javier Escaned, MD, PhD, Interventional Cardiologist at Hospital Clínico San Carlos, Madrid, Spain. “The ADVISE II study is the first prospective test of the true iFR algorithm that is analyzed through an independent physiology core lab (Cardialysis, Rotterdam, Netherlands). These preliminary results show that the prior observations can be replicated prospectively, and that a Hybrid iFR/FFR approach can provide a greater than 90% agreement with FFR while saving the use of hyperemic agent in more than half of patients.”
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.
Also presented this week were results from the first 392 real-time cases performed live in the cath lab from more than 20 centers in Europe, Japan and South Africa that are now equipped with the iFR® software. These results confirmed the prior results and those of the preliminary ADVISE II findings being presented at EuroPCR.
“After using iFR in real world clinical practice, its simplicity is clearly its strength. In a busy cath lab, saving time is important and the results in my early experience have been consistent and clinically useful,” commented Andrew Sharp , MD, Interventional Cardiologist at Royal Devon & Exeter Hospital, Exeter, United Kingdom. “Once real-world operators have the opportunity to use both of these complementary technologies, I think they will be impressed.”