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Volcano Corporation Commends the Elevation of FFR to Level of Evidence A in New PCI Guidelines
Date:12/22/2009

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
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SOURCE Volcano Corporation
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