Volcano Announces Preliminary Results from the ADVISE II Study and Inclusion in the SYNTAX2 Trial During Hot Line Late Breaking Clinical Trial Sessions at EuroPCR 2013 Prospective, Multi-Center, Double-Blinded Study Confirms Prior Results in evaluating Volcano's iFR® (Instant Wave-Free Ratio™) Software Modality in a Large, Real-World Population
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."
Also announced at EuroPCR 2013 was the investigator-led SYNTAX2 study, which will be co-sponsored by Volcano and Boston Scientific Corporation. SYNTAX2 is designed to test precision guided percutaneous coronary intervention (PCI), using a clinical SYNTAX score as derived at Cardialysis in Rotterdam along with live iFR®/FFR Hybrid measurements of the vessel to determine which patients and lesions are treated. Boston Scientific SYNERGY™ drug-eluting stents will then be placed with IVUS guidance, using both Volcano and Boston Scientific IVUS devices, to provide more accurate stent placement than has been demonstrated with angiography alone.
"Modern-day stent design and techniques have improved dramatically since the very first SYNTAX study was enrolled more than five years ago," commented Professor Patrick Serruys, Rotterdam, Netherlands. "It is widely believed in the community that PCI is an excellent alternative to coronary bypass surgery in the right patients. The SYNTAX2 study will use a new 'clinical SYNTAX score' to first identify prospective patients we believe will benefit from a less-invasive PCI procedure, and then use physiology and IVUS guidance along with the modern-day drug-eluting stent technology. The goal is to show that delivering the most precise and modern-day PCI possible will allow more patients to be treated with this excellent alternative to bypass surgery."
"The fact that iFR has now been validated in more than 3,000 patients as part of these studies makes us comfortable in our understanding of the performance of the tool," commented Michel Lussier, President of Scientific and Clinical Affairs at Volcano. "iFR is not a replacement for FFR given the wealth of outcome data generated over the years in DEFER, FAME and FAME II. Future studies like SYNTAX2 that include iFR will now focus on clinical, economic and quality of life outcomes rather than comparisons to FFR now that those questions have been answered. This is an exciting time and we look forward to offering this tool to clinicians and interested researchers around the world to further the evidence that physiology can provide that next leap in improving PCI."
About Volcano Corporation
Volcano Corporation is revolutionizing the medical device industry with a broad suite of technologies that make imaging and therapy simpler, more informative and less invasive. Our products empower physicians around the world with a new generation of analytical tools that deliver more meaningful information - using sound and light as the guiding elements. Founded in cardiovascular care and expanding into other specialties, Volcano is changing the assumption about what is possible in improving patient outcomes by combining imaging and therapy together.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered "forward-looking statements." including statements regarding the potential benefits of the products and technologies described above, further development and expansion, anticipated clinical trials and the impact of clinical and other technical data. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause Volcano's results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ include the pace and extent of market adoption of the company's products and technologies; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; growth strategies; timing and achievement of product development milestones; outcome of ongoing litigation; the impact and benefits of market development; product introductions; unexpected new data, safety and technical issues; market conditions; and other risks inherent to medical device development and commercialization. These and additional risks and uncertainties are more fully described in Volcano's filings made with the Securities and Exchange Commission, including our recent quarterly report on Form 10-Q. Undue reliance should not be placed on forward-looking statements which speak only as of the date they are made. Volcano undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
SOURCE Volcano Corporation