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Volcano Corporation Praises FAME Study Results

SAN FRANCISCO, Sept. 23 /PRNewswire-FirstCall/ -- 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, said today that the two-year results of the Fractional Flow Reserve (FFR) vs. Angiography for Multivessel Evaluation (FAME) study confirm the importance of FFR in improving patient outcomes and reducing hospital costs. The findings were released today during the 2009 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco.

The results of the prospective, multi-center trial at 12-months, originally published in the New England Journal of Medicine in 2009, demonstrate that patients with multi-vessel coronary artery disease who were treated by FFR guidance had a 34% reduction in death and myocardial infarction (MI) compared to angiographic guidance alone. The clinical benefit of FFR-guidance at two years showed the sustained reduction in death and heart attacks of 34%. The study also demonstrated that adhering to an FFR-guided regimen for multi-vessel disease provides cost benefits to the hospital and payers by reducing procedural costs by $675 and lowering average length of hospitalization. The data also showed that the implementation of FFR did not add time to the multi-vessel percutaneous interventional (PCI) procedure.

William F. Fearon, M.D., associate director of interventional cardiology at Stanford University Medical Center, Palo Alto, California commented, "Use of FFR technology represents a rare opportunity in medicine in which an innovative product not only improves clinical outcomes but also saves money."

"The FAME study results reaffirm that angiography alone is not enough," said Scott Huennekens, president and CEO of Volcano. "Better patient outcomes and lower costs are key global objectives and central topics in the U.S. healthcare reform debate. This study demonstrates significant clinical and economic benefits of FFR when used routinely to guide treatments of multi-vessel disease."

FAME randomized 1,005 patients diagnosed with multi-vessel coronary artery disease at 20 European and United States centers to either angiography-guided PCI (n=496) or FFR-guided PCI (n=509) all using current drug regimens. Some physicians have been concerned that the lesions deferred by FFR may progress and cause future events. In the FAME study, 513 total lesions were deferred and only one of those lesions led to a myocardial infarction (heart attack) within two years (0.2 %). This highlights the effectiveness of using a 0.80 FFR threshold for triaging this multi-vessel disease patient population.

"FAME is among the most important studies in today's drug eluting stent era," said Huennekens. "FAME data has driven a significant increase in the use of FFR in the last year, but despite the clear and positive clinical and economic impact of FFR guided PCI, without direct reimbursement for FFR, physicians are often discouraged from using the tool because the line item cost for the FFR wires is perceived as an added expense to the hospital. This is a perfect example of where the current U.S. reimbursement system works against patients, physicians and hospitals because it drives doctors away from these beneficial and proven guidance tools. The data show that both patients and hospitals benefit, yet the reimbursement structure may be slowing adoption of the technology."

Volcano estimates that multi-vessel disease is treated in approximately 35% of all U.S. PCI (a combination of mutli-vessel stenting and patients who are staged and treated during two separate visits). By applying the FAME results across that patient population, the reduction in MACE and assuming $675 per procedure cost savings would result in approximately 18,000 fewer MACE events per year at a total hospital cost savings of approximately $230 million or over $2 billion in the 10 years outlined for the new healthcare reform package. If you count the cost savings included in the MACE reductions, as presented at ESC 2009 ($2,066 per patient) that potential total cost impact could be more than $700 million per year, and $7 billion over 10 years.

Huennekens continued, "In the end, physicians want to do what is best for the patient. The data from FAME in support of FFR-guided PCI has clearly been strong enough to change practice, as sales of our disposable FFR wire products through the first half of 2009 have grown nearly 80 percent year over year. The extended 2-year follow-up data presented today from FAME provides further evidence of clinical benefit and hopefully continues to support changing physician guidelines as well as reimbursement practices."

About Volcano Corporation

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(R) IVUS tissue characterization and ChromaFlo(R). 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) and Forward-Looking IVUS systems and catheters. Currently, more than 4,400 Volcano IVUS and FM systems are installed worldwide, and more than half of Volcano's revenues are derived from outside the United States. Through its wholly-owned subsidiary, Axsun Technologies, Volcano also develops and manufactures optical monitors, lasers and optical engines used in telecommunications, spectroscopy and other industrial applications. These products are sold to a variety of customers, including Nokia Siemens, Ericsson, Alcatel-Lucent and HuaWei Technologies. For more information, visit the company's website at

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 potential clinical and economic impact of FFR-guidance and related FAME data, market adoption of the company's technology, the impact of clinical and other technical data and reimbursement policies, 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 are made, or to reflect the occurrence of unanticipated events.

SOURCE Volcano Corporation
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