-- Volcano Highlights Two Products Intended to Expand the Role of Physiology in the Cath Lab
SAN DIEGO, May 21, 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 that it will demonstrate the Verrata™ Pressure Guide Wire and the iFR® (Instant wave-Free Ratio™) modality throughout the week during the EuroPCR 2013 Congress in Paris, France. These two interventional tools are intended to help physicians guide more procedures and make more decisions based on actual heart function, rather than relying on the angiogram alone.
"Despite all the questions that surround percutaneous coronary interventions (PCI) today, there is an exciting evolution taking place in the form of more precise stenting decisions and guidance with physiology tools like Fractional Flow Reserve (FFR)," commented Joe Burnett, Executive Vice President and General Manager of the Functional Management Business Unit at Volcano. "Data from the DEFER, FAME and FAME II trials have repeatedly provided evidence that FFR is the best and most evidence-based diagnostic tool available to help properly diagnose a patient's vessel, or even a specific blockage. In the five years since FAME, it is increasingly uncommon that a physician makes a decision based on angiography alone, without some sort of functional assessment being performed. We believe that FFR is the most proven vessel-specific assessment available."
"Physiology will continue to evolve," added Burnett. "Even though FFR is routinely used to decide if a patient needs treatment, daily practice often reverts back to the basic angiogram to select which lesions get treated and to confirm the treatment was successful. There is a tremendous amount of information physiology can provide that we have yet to unlock in daily practice. The Verrata wire and iFR modality are designed to continue that evolution to allow physicians to quickly and easily get valuable functional information throughout a stent procedure."
The Verrata™ Pressure Guide Wire will be Volcano's fifth new pressure guide wire in the past five years. It embodies a new wire design and workflow designed to facilitate fast, simple connections and re-connections throughout a procedure. "The proposed workflow of the new wire is ideal because it would more closely mimic standard guidewire use in everyday practice," commented Bruce Samuels, MD of Cedars-Sinai Hospital in Los Angeles, CA. "The biggest difference between an everyday interventional wire and a pressure wire is the large, heavy connector that resides on the end. The design of the new Verrata wire would allow me to very quickly and easily disconnect and reconnect the wire with no interruption to my workflow. Re-connecting a pressure wire is now faster than re-connecting the indeflator for a stent delivery system, which would allow me to steer the Verrata wire just like a standard interventional wire with no connector, and simply reconnect any time I want to take a measurement. This is ideal for delivering devices like balloons and stents over the wire, and then making valuable physiologic measurements after each step. I can forsee the functional improvement that my therapy will have on the patient and not be forced to only trust the angiogram."
Our new iFR® software modality was developed in concert with Imperial College London. Using the same pressure wire and equipment currently used for FFR, iFR® amplifies the patient's physiologic measurements during resting conditions before stressing the heart with a commonly used vasodilator drug, like Adenosine.
"I continue to be amazed at how inaccurate the angiogram can be," commented Matthias Gotberg, Interventional Cardiologist, Department of Coronary Heart Disease, Skane University Hospital, Lund, Sweden. "Physiology uncovers very important functional information that simply disagrees with the angiogram and should not be ignored. By making this meaningful measurement in seconds, physicians can get physiologic answers, but in a workflow almost identical to how they perform angiographic PCI today. In essence, you can repeatedly double-check the angiogram with actual heart function and add very little time to your procedure. I have had access to the live software for more than three months now. Quite simply, today I am making functional measurements with iFR that before I would have left to angiography alone."
"iFR and FFR look at the same lesion, but from two different viewpoints," said Justin Davies, MBBS, MRCP, PhD, of Imperial College London. "FFR will always be an important tool for us in the lab. It creates a 'worst-case-scenario' to rule out ischemia, and patients with a negative FFR test do very well clinically with medical therapy alone. At the same time, retrospective iFR core lab analysis in over 1,500 patients suggests that more than half of our patients could avoid the need for hyperemic drugs and still benefit from the proven value of these physiologic assessments. ADVISE II will be the very first prospective, multi-center independent study using the currently available Volcano/Imperial iFR algorithm to seek to confirm this hypothesis."
Results from the first 300 ADVISE II patients will be presented at EuroPCR as part of the Hot Line late-breaking clinical trial session on Thursday, May 23rd at 10:09 AM in Room 351.
Both the Verrata™ Pressure Wire and the iFR® software modality will be compatible with Volcano's multi-modality imaging systems including the latest CORE™ Integrated System which will also be on display at EuroPCR 2013. iFR® is currently active in more than 20 centers around the world. Hospitals in London, Rotterdam and Johannesburg will be transmitting live iFR® cases throughout this week at PCR. "These two new tools will make physiology more accessible and mainstream, and that is a good thing for hospitals and patients," continued Burnett. "The easier it is for a physician to double-check the angiogram, the better. Having both iFR and FFR on the same system, just one click away, only expands the options to do so. This is a very exciting time for Volcano's physiology program as we are executing our vision of a frontline interventional wire workflow that can quickly and easily provide functional information beyond angiography."
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 evolution of physiology, anticipated new product introductions, including the Verrata™ Pressure Guide Wire and iFR® software modality, uses and potential benefits of these new products, and potential new products and workflows. 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.
 Verrata™ Pressure Guide Wire is pending 510(k) and CE mark, and is not commercially available for sale. Our iFR® software modality is approved in CE mark countries.
SOURCE Volcano Corporation