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Volcano: 1,000 iFR Systems in Use Worldwide
Approved in U.S. in March, Instant Wave-Free Ratio is Gaining Users
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December 16, 2014 -- Volcano Corporation (NASDAQ: VOLC) has announced that 1,000 iFR ((instant wave-Free Ratio™) systems have now been activated worldwide. iFR was approved by the U.S. FDA in March of this year and is being used increasingly in cath labs to assist in decision-making (to stent or not to stent and, if so, which blockage is the correct one to stent).
Although iFR and FFR and both methods of functional measurement, in which the extent of a coronary or peripheral blockage is assessed using flow characteristics, rather than the visual "guess-timate" approach of coronary angiography alone, one of the key differences is that iFR does not require the use of adenosine, and can be performed instantly, before, during and post-procedure.
Some background on these technologies:
iFR: A New Method of Functional Measurement
iFR represents a significant advance in the field of functional measurement (FM), in which the actual flow pressures inside the coronary artery can be measured and the deficit caused by a coronary blockage or lesion can be accurately assessed. The primary modality in FM has been FFR (Fractional Flow Reserve).
A number of studies utilizing FFR have demonstrated that outcomes of PCI (stenting and angioplasty) are significantly improved when FFR is used: blockages that measure 0.80 or less are considered ischemic and should be opened; those that measure greater than 0.80 are not considered ischemic, even though they may look significant on the angiogram, and can safely be left alone. In fact, dilating non-significant lesions can lead to negative outcomes, because the risk inherent in a PCI procedure outweighs the possible benefit of stenting. The DEFER, FAME and FAME II trials all showed that functional measurement trumped angiography for decision-making in PCI. In FAME, the use of FFR reduced the number of stents by a third, and improved outcomes by the same amount.
iFR: Simpler, More Cost-Effective, Expanded Use as Guidance Tool
iFR does not need adenosine for measurement of intracoronary pressures. The specifics of how iFR accomplishes this can be read in Angioplasty.Org's interview with one of iFR's developers, Dr. Justin E. Davies of Imperial College London. The elimination of adenosine has several advantages: (1) lower cost, since the drug itself and associated administration costs are eliminated; (2) faster, since a pressure wire can be advanced instantly during the procedure without waiting for the drug to be injected; (3) greater patient comfort; (4) expanded use as a tool to guide and assess the procedure's success.
This last point is a very important one that has the potential to make PCI more efficient and effective. The iFR wire can quickly be moved from one lesion to another in arteries that have multiple blockages to, first of all, determine which of them are ischemic and candidates for stenting. But the iFR wire can also be used very quickly during the procedure to see if, in fact, the stent has improved the pressure or if further expansion or additional work is necessary.
FFR has mainly been used to justify an intervention (or to safely defer it). iFR has the potential to help guide the procedure in real-time and assess its success instantaneously on the cath lab table.
Yesterday's press release from Volcano Corporation follows:
Volcano Announces 1,000th System Activated with its iFR® (instant wave-Free Ratio™) Modality Worldwide
December 15, 2014 -- San Diego -- Volcano Corporation (NASDAQ: VOLC), a leading company focused on improving patient and economic outcomes on a global basis by developing and delivering innovative minimally invasive coronary and peripheral visualization, physiology diagnostics and therapies, today announced that more than 1,000 systems have been activated with its instant wave-Free Ratio™, or iFR® Modality software, allowing physicians and patients around the globe to benefit from the simplified workflow, and reduced need for hyperemic agents.
The iFR® Modality is a physiologic measurement performed using the same pressure wires and equipment utilized in cardiac catheterization labs for Fractional Flow Reserve (FFR), but avoids injection of hyperemic agents into the patient that induce stress to the heart. This allows for a meaningful, lesion-specific assessment in seconds by amplifying the resting pressure waveform. The iFR® Modality is used most efficiently with Volcano's widely adopted Verrata™ Pressure Guide Wire, which is designed for simple disconnection and reattachment during a procedure, and facilitates multiple quick measurements without the need for hyperemic agents.
"We believe that coronary physiology, of any kind, provides tremendous value to help drive appropriate therapy in patients," commented Andrew Tochterman, Director and Functional Management Segment Leader at Volcano Corporation. "As a result, technologies like iFR®, that remove the extra time and cost of hyperemia, have the potential to increase adoption of coronary physiology and further optimize patient care. We are extremely pleased with the pace of adoption of the iFR® Modality and Verrata. Physicians are quick to comment on the improved workflow, and potential cost savings associated with the iFR® Modality. The rate of adoption in the United States has truly surpassed our expectations, indicating that tools to improve workflow, and reduce costs are preferred by clinicians and administrators."
The iFR® Modality and other physiologic guidance tools including FFR and Coronary Flow Reserve (CFR), are currently being studied in numerous prospective clinical trials as part of the DEFINE family of studies. These studies are designed to explore patient outcomes in a broad array of clinical presentations in more than 5,000 patients worldwide. The performance of the iFR® Modality has been tested in approximately 800 patients as part of ADVISE II (Adenosine Vasodilator Independent Stenosis Evaluation), the first prospective, real world registry comparing iFR® and FFR. The iFR® Hybrid Approach Analysis performed in the ADVISE II Study demonstrated a statistically high correlation (sensitivity 90.7% for FFR less than or equal to 0.80, specificity 96.2% for FFR greater than 0.80). The hybrid method would have avoided the need to use a hyperemic agent in 65.1% of this patient population. Patients in ADVISE II were recruited from more than 40 centers in the United States and Europe, and all procedures were performed with operators blinded to the iFR® values which were calculated offline at an independent core laboratory in Rotterdam, the Netherlands.
"We chose to evaluate the hyperemic savings in our own subset of patients and have been very pleased with iFR®," commented Vincent J. Pompili, MD, FACC, Director, Interventional Cardiovascular Medicine and Cardiac Catheterization Laboratories at The Ross Heart Hospital at The Ohio State University Wexner Medical Center. "In our subset of patients thus far, we've seen more than a 60% reduction in the need for hyperemic agents using the iFR® Hybrid Approach, which is consistent with the ADVISE II Study. Our patients appreciate not having to receive a hyperemic agent but still receive the benefits of intracoronary physiologic measurements. So far I have been impressed with the ease of use, and repeatability of the software."
About Volcano Corporation
Through its multi-modality platform, Volcano Corporation is the global leader in intravascular imaging for coronary and peripheral therapeutic devices. The company's broad range of technologies makes imaging and therapy simpler, more informative and less invasive and offers physicians and their patients around the world with industry-leading tools that aid diagnosis and guide and provide therapy. Founded in cardiovascular care and expanding into other specialties, Volcano is focused on improving patient and economic outcomes. For more information, visit the company's website at www.volcanocorp.com.
Forward-Looking Statements
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.
Reported by Burt Cohen, December 16, 2014
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