Volcano Reacts Positively to the New European PCI Guidelines That Raise FFR-Guided PCI to a Class I, Level of Evidence a Recommendation

SAN DIEGO, Sept. 22 /PRNewswire-FirstCall/ -- Volcano Corporation (Nasdaq: VOLC) today announced its support for the elevation of Fractional Flow Reserve-guided PCI in the new guidelines from the Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). This is consistent with the ACC/AHA STEMI and PCI Guidelines and its 2009 update of Fractional Flow Reserve (FFR) to Level of Evidence A as well. FFR measures the range of pressure across a blood vessel. Specifically, the new guidelines recommend FFR to help detect ischemic-related lesions, when an imaging stress test is not available. Two scientific studies, FAME (Fractional Flow Reserve vs. Angiography in Multi-Vessel Coronary Disease) and DEFER (Deferral Versus Performance of PTCA in Patients Without Documented Ischemia), provided additional evidence for how avoiding unnecessary stenting improves patient outcomes.

"Volcano applauds the proactive efforts of the ESC and EACTS to utilize the strong evidence from studies like FAME and DEFER and update the guidelines on how physicians should use FFR-guided PCI to help patients," said Michel Lussier, Group President for Advanced Imaging Systems, Scientific Affairs, and Europe, Africa, and the Middle East (EAME). "FFR has already gained broad acceptance in countries such as Belgium, the Netherlands, Germany and the UK. Hopefully, the Pan-European nature of the guidelines will broaden adoption within other countries."

The new guidelines recognize that when patients arrive at the cardiac catheterization laboratory without a non-invasive imaging stress test, additional information about the severity of their coronary artery disease can validate the extent of treatment that patient might need. The ESC and EACTS recommend the use of FFR to assess if a blocked vessel is at risk of rupturing or creating ischemia, and/or if stent placement will be helpful, particularly when multi-vessel disease is present.

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%.

The DEFER Trial concluded that patients treated based on fractional flow reserve (FFR) results had achieved long-term outcomes equal to or better than patients who underwent stenting solely based on angiographic evidence.

Bernard DeBruyne, M.D., Ph.D, Interventional Cardiologist at OLV Aalst, Belgium and early pioneer of the technique,  commented, "In addition to the clinical evidence supporting the use of FFR, the further substantiation of this important technology by the European societies will enable physicians to feel even more confident in their ability to meet the needs of patients with complex artery disease."

There are both clinical and economic benefits to FFR. 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.

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 PRESTIGE™, PrimeWire®, FloWire®, and ComboWire® XT, and three supporting consoles. Volcano's s5 consoles are the only multi-modality systems with IVUS and FFR on the market today. Volcano's s5 consoles are the only multi-modality systems on the market today that offer both intravascular imaging and FFR.

About Volcano Corporation

Volcano Corporation is revolutionizing the medical device industry with a broad suite of technologies that make imaging and therapy simpler, more informative and less invasive.   Our products empower physicians around the world with a new generation of analytical tools that deliver more meaningful information - using sound and light as the guiding elements.  Founded in cardiovascular care and expanding into other specialties, Volcano is changing the assumption about what is possible in improving patient outcomes by combining imaging and therapy together.  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 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, further development and expansion, regulatory approval, commercial release and market adoption of the company's technology, results and implications of the data from the FAME and DEFER trials, 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, including the current report on Form 8-K filed September 13, 2010. 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