Healthcare Industry News: fractional flow reserve
News Release - January 20, 2009
Volcano Highlights Commitment, Market Acceptance of FFR Product LineCompany expects market awareness of FAME data will fuel continued growth in PrimeWire(TM) and s5-FFR console demand
SAN DIEGO, Jan. 20 (Healthcare Sales & Marketing Network) -- Volcano Corporation (Nasdaq: VOLC ), a leader in the development, manufacturing and sales of products for the diagnosis and treatment of coronary and peripheral artery disease, today commented on the increased demand for their FFR and IVUS capable consoles, as well as their FFR pressure guide wires following the TCT announcement of the FAME study results.
Joe Burnett, Vice President of Marketing at Volcano Corp commented, "The rapid market acceptance of the FAME data, and heightened awareness around FFR guided PCI technique has been captured clearly by the increased interest in our pressure guide wires and FFR functionality on our s5 family of imaging consoles. Since the FAME study was presented in at the TCT in October, we have experienced growing receptivity in the market to our FFR offerings. The FFR option for our s5i integrated imaging console was included in more than 90% of all new orders, which is again evidence that physicians and hospitals are demanding access to this reinvigorated technology. The expanding FFR capable installed base, and the increased procedural speed of FFR systems that are physically integrated into each cath lab room, is further fueling the impact of FAME."
The FAME study, published in the New England Journal of Medicine, demonstrated that using FFR guidance in addition to angiography can reduce mortality and myocardial infarction by 34% at one year. The study also demonstrated that these improved clinical outcomes were complemented by reduced cost to the hospitals involved in the trial. "The FAME study is among the most important studies in today's DES therapy era. FAME demonstrates that when physicians employ FFR to guide multi-vessel PCI treatment, their patients benefit both clinically and economically. The FFR-guided interventions for multi-vessel disease are also cost effective for hospitals and payers. FAME confirms the benefits of routine FFR for the multi-vessel patient just as the earlier Deferral versus Performance of PTCA in Patients Without Documented ischemia (DEFER) study demonstrated in single-vessel disease, but does so in a larger patient population and in a randomized fashion," commented Morton Kern, MD, professor of medicine and associate chief, Division of Cardiology, University of California, Irvine.
FAME randomized 1005 patients diagnosed with multi-vessel coronary artery disease at 20 European and US centers to either angiography-guided PCI (n=496) or FFR-guided PCI (n=509) all using current DES regimens. FAME's objective was to compare angiographic guidance to FFR guidance and to determine which coronary lesions required revascularization. FAME demonstrated that FFR-guidance in routine multi-vessel PCI resulted in clinically-superior outcomes and reduced the composite of death, documented myocardial infarction, and repeat revascularization by 30 percent at one year. The study also demonstrated that adhering to an FFR-guided regimen for multi-vessel disease is cost beneficial to the hospital and payers by reducing procedural costs ($5,332 vs. $6,007), lowering average length of hospitalization (3.4 days vs. 3.7 days), and reducing the number of drug eluting-stents necessary per patient (1.9 vs. 2.7). The data also showed that the implementation of FFR did not add time to the multi-vessel PCI procedure.
"Angiography alone does not tell the whole story, and can even be misleading," continued Burnett. "FFR is now a well validated and readily available tool, which can quickly guide physicians to ischemia producing lesions that benefit most from stent placement. The number of multi-vessel disease cases worldwide is significant, and if adopting FFR can both improve patient outcomes and reduce hospital costs, we believe we are at the very beginning of market penetration given today's economic environment."
Volcano Corporation (Nasdaq: VOLC ) offers a broad suite of devices designed to facilitate endovascular procedures, enhance the diagnosis of vascular and structural heart disease and guide optimal therapies. The company's intravascular ultrasound (IVUS) product line includes ultrasound consoles that can be integrated directly into virtually any modern cath lab. Volcano IVUS offers unique features, including both single-use phased array and rotational IVUS imaging catheters, and advanced functionality options, such as VH® IVUS tissue characterization and ChromaFlo®. Volcano also provides functional measurement (FM) consoles and single-use pressure and flow guide wires and is developing a line of ultra-high resolution Optical Coherence Tomography (OCT) systems and catheters. Currently, more than 3,700 Volcano IVUS and FM systems are installed worldwide, with approximately half of its revenues coming from outside the United States. For more information, visit the company's website at http://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 regarding Volcano's business that are not historical facts may be considered "forward-looking statements," including statements regarding the features, functionality and potential benefits of our products and patient outcomes, market awareness, acceptance and adoption of the company's technology, the impact of clinical and other technical data, the safety, cost and efficacy of the company's products, the success and timing of product development and clinical trial programs, growth and market development, and product sales. Forward-looking statements are based on management's current preliminary 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 from the results predicted are detailed in the company's annual report on Form 10-K, quarterly reports on Form 10-Q and other filings made with the Securities and Exchange Commission. 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 were made, or to reflect the occurrence of unanticipated events.
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