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Volcano Corporation Praises FAME Study Results
Date:9/23/2009

resident 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 populatio
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SOURCE Volcano Corporation
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