SAN DIEGO, Jan. 20 Volcano Corporation(Nasdaq: VOLC), a leader in the development, manufacturing and sales ofproducts for the diagnosis and treatment of coronary and peripheral arterydisease, today commented on the increased demand for their FFR and IVUScapable consoles, as well as their FFR pressure guide wires following the TCTannouncement of the FAME study results.
Joe Burnett, Vice President of Marketing at Volcano Corp commented, "Therapid market acceptance of the FAME data, and heightened awareness around FFRguided PCI technique has been captured clearly by the increased interest inour pressure guide wires and FFR functionality on our s5 family of imagingconsoles. Since the FAME study was presented in at the TCT in October, we haveexperienced growing receptivity in the market to our FFR offerings. The FFRoption for our s5i integrated imaging console was included in more than 90% ofall new orders, which is again evidence that physicians and hospitals aredemanding access to this reinvigorated technology. The expanding FFR capableinstalled base, and the increased procedural speed of FFR systems that arephysically integrated into each cath lab room, is further fueling the impactof FAME."
The FAME study, published in the New England Journal of Medicine,demonstrated that using FFR guidance in addition to angiography can reducemortality and myocardial infarction by 34% at one year. The study alsodemonstrated that these improved clinical outcomes were complemented byreduced cost to the hospitals involved in the trial. "The FAME study is amongthe most important studies in today's DES therapy era. FAME demonstrates thatwhen physicians employ FFR to guide multi-vessel PCI treatment, their patientsbenefit both clinically and economically. The FFR-guided interventions formulti-vessel disease are also cost effective for hospitals and payers. FAMEconfirms the benefits of routine FFR for the multi-vessel patient just as theearlier Deferral versus Performance of PTCA in Patients Without Documentedischemia (DEFER) study demonstrated in single-vessel disease, but does so in alarger 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 arterydisease 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 wasto compare angiographic guidance to FFR guidance and to determine whichcoronary lesions required revascularization. FAME demonstrated thatFFR-guidance in routine multi-vessel PCI resulted in clinically-superioroutcomes and reduced the composite of death, documented myocardial infarction,and repeat revascularization by 30 percent at one year. The study alsodemonstrated that adhering to an FFR-guided regimen for multi-vessel diseaseis 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 perpatient (1.9 vs. 2.7). The data also showed that the implementation of FFR didnot add time to the multi-vessel PCI procedure.
"Angiography alone does not tell the whole story, and can even bemisleading," continued Burnett. "FFR is now a well validated and readilyavailable tool, which can quickly guide physicians to ischemia producinglesions that benefit most from stent placement. The number of multi-vesseldisease cases worldwide is significant, and if adopting FFR can both improvepatient outcomes and reduce hospital costs, we believe we are at the verybeginning of market penetration given today's economic environment."
Volcano Corporation (Nasdaq: VOLC) offers a broad suite of devicesdesigned to facilitate endovascular procedures, enhance the diagnosis ofvascular and structural heart disease and guide optimal therapies. Thecompany's intravascular ultrasound (IVUS) product line includes ultrasoundconsoles that can be integrated directly into virtually any modern cath lab.Volcano IVUS offers unique features, including both single-use phased arrayand rotational IVUS imaging catheters, and advanced functionality options,such as VH(R) IVUS tissue characterization and ChromaFlo(R). Volcano alsoprovides functional measurement (FM) consoles and single-use pressure and flowguide wires and is developing a line of ultra-high resolution OpticalCoherence Tomography (OCT) systems and catheters. Currently, more than 3,700Volcano IVUS and FM systems are installed worldwide, with approximately halfof 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 meaningof the U.S. Private Securities Litigation Reform Act of 1995. Any statementsin this release regarding Volcano's business that are not historical facts maybe considered "forward-looking statements," including statements regarding thefeatures, functionality and potential benefits of our products and patientoutcomes, market awareness, acceptance and adoption of the company'stechnology, the impact of clinical and other technical data, the safety, costand efficacy of the company's products, the success and timing of productdevelopment and clinical trial programs, growth and market development, andproduct sales. Forward-looking statements are based on management's currentpreliminary expectations and are subject to risks and uncertainties, which maycause Volcano's results to differ materially and adversely from the statementscontained herein. Some of the potential risks and uncertainties that couldcause actual results to differ from the results predicted are detailed in thecompany's annual report on Form 10-K, quarterly reports on Form 10-Q and otherfilings made with the Securities and Exchange Commission. Undue relianceshould not be placed on forward-looking statements, which speak only as of thedate they are made. Volcano undertakes no obligation to update anyforward-looking statements to reflect new information, events or circumstancesafter the date they were made, or to reflect the occurrence of unanticipatedevents.
SOURCE Volcano Corporation