Healthcare Industry News:  peripheral artery disease 

Devices Interventional Cardiology

 News Release - December 22, 2009

Volcano Corporation Commends the Elevation of FFR to Level of Evidence A in New PCI Guidelines

Volcano expects these guidelines to broaden usage of FFR in the U.S.

SAN DIEGO, Dec. 22 (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, reacted positively to the new guidelines for treating coronary disease and heart attacks using percutaneous coronary intervention (PCI), a procedure that treats narrowed blood vessels. Based on the strength of the latest clinical data supporting the usage of Fractional Flow Reserve (FFR), the American Heart Association (AHA), the American College of Cardiology (ACC), and the Society for Cardiovascular Angiography and Interventions (SCAI) elevated the level of evidence for FFR in their guidelines from Level B to Level A, the highest level possible. FFR, a Volcano therapy guidance metric, is determined by using a small pressure wire that is threaded into a coronary artery, and measures the range of pressure across a blockage. The guidelines suggest that FFR can be useful to evaluate intermediate blockages in coronary arteries, determine which lesions will benefit from stenting, and which should be treated with medical therapy alone.

"Volcano commends the AHA, ACC and SCAI for responding so quickly to new data, like the FAME study, to revise their guidelines on how to best treat patients with severe coronary artery disease," said Scott Huennekens, President and CEO of Volcano. "Many medical guidelines are being reviewed and many patients are being told less screening is better. Most recently, scans similar to angiography have been projected to increase the risk of cancer, when done excessively or unnecessarily, as they expose the patient to increased radiation. These new recommendations highlight the benefit of using highly localized therapy guidance technology like FFR to go beyond the limits of angiography and more precisely pinpoint the severity of coronary disease on a lesion-by-lesion basis. Our FFR sales are up 73% year-to-date as compared with the same period a year ago, and we expect the elevation of the evidence supporting FFR to result in even more usage by physicians."

Recent studies have shown that using FFR can provide better treatment guidance than just relying on angiography alone. FAME, a multi-center randomized clinical trial originally published in the New England Journal of Medicine in 2009, demonstrated that multi-vessel procedures guided by FFR (instead of angiography alone) led to both better outcomes and reduced procedural costs. The study found that after two years, patients with multi-vessel coronary artery disease whose doctors used FFR guidance had a sustained 34% reduction in death and heart attacks. The data also showed that intermediate lesions by x-ray (judged to be 50-70% blocked) were in fact flow limiting 39% of the time – suggesting that intervention would have reduced ischemia. Conversely, these intermediate lesions were non-flow limiting or 'non-ischemic' 61% of the time and the data show that treating non-ischemic lesions with medical therapy alone led to only one myocardial infarction out of 513 measured blockages at two years, or a rate of only 0.2%.

John Hodgson, M.D., FACC, FSCAI and Chairman of Cardiology for Geisinger Health System commented, "The FAME study provides very compelling evidence that angiographic imaging alone should not be used to triage intermediate lesions. The simple fact that similar-appearing angiographic stenoses can be significant 39% of the time and insignificant 61% of the time (in terms of causing or not causing ischemia) highlights the limitations of the angiogram in making these important clinical and economic decisions. How can you rely only on an angiogram to make a decision to stent or not-stent if the data suggest that you will be wrong either 39% of the time or 61% of the time?"

"Realizing the limitations of the angiogram is not a huge surprise, but a key question that many physicians want answered is 'How often does the FFR get it wrong, and what are the consequences when that occurs?'" continued Hodgson. "One of the most compelling data points for me is that of the 513 lesions in FAME participants that FFR defined as 'non-ischemic' which were -- as a result -- not stented, only one of those lesions led to an MI after two years, or only 0.2%. That is remarkable. We must remember that every stent implanted has its own unique and real risk of adverse events - placing these stents is not 'free' from a patient risk perspective. Needless to say, I am very pleased that the ACC and AHA used FAME as an important reference point to upgrade the guidelines for FFR in intermediate lesions from Level B to Level A evidence."

The FAME study also demonstrated that adhering to an FFR-guided regimen for multi-vessel disease is cost-beneficial to the hospital and payers by reducing material costs by $675 per patient, lowering average length of hospitalization by 0.3 days and reducing the total patient treatment cost at 12-months by more than $2,000.

"FFR is not an expensive or cumbersome technology," according to Hodgson. "In fact, it is quite fast, easy to use, and available in virtually every cath lab in the United States and across Europe. Since FFR is widely available, can reduce risk for the patient and lowers health care costs, it is time for the interventional cardiology community to make FFR a part of their regular clinical routine. Here at Geisinger, we are integrating it into our ProvenPCI(SM) protocols to ensure that all patients get what evidence tells us is optimal care."

Patients diagnosed with heart disease are encouraged to talk to their physicians about treatment options. Treatments should be personalized to meet the individual needs of each patient and should take into consideration many risk factors including age and family history. Volcano advises patients to also educate themselves about the various treatment options available to them, including the use of FFR, when making important health care decisions. Only Volcano has the broadest FFR product portfolio, which includes the PrimeWire®, FloWire®, and ComboWire® XT, and three supporting consoles.

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® 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) and Forward Looking IVUS systems and catheters. Currently, more than 4,700 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 benefits of the products and procedures described above, results and implications of the data from the FAME trial, commercial release and market adoption of the company's technology, and the impact of clinical and other technical data. 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

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