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Volcano Highlights Commitment, Market Acceptance of FFR Product Line
Date:1/20/2009

for multi-vessel disease are also cost effective for hospitals and payers. FAME confirms the benefits of routine FFR for the multi-vessel patient just as the earlier Deferral versus Performance of PTCA in Patients Without Documented ischemia (DEFER) study demonstrated in single-vessel disease, but does so in a larger patient population and in a randomized fashion," commented Morton Kern, MD, professor of medicine and associate chief, Division of Cardiology, University of California, Irvine.

FAME randomized 1005 patients diagnosed with multi-vessel coronary artery disease at 20 European and US centers to either angiography-guided PCI (n=496) or FFR-guided PCI (n=509) all using current DES regimens. FAME's objective was to compare angiographic guidance to FFR guidance and to determine which coronary lesions required revascularization. FAME demonstrated that FFR-guidance in routine multi-vessel PCI resulted in clinically-superior outcomes and reduced the composite of death, documented myocardial infarction, and repeat revascularization by 30 percent at one year. The study also demonstrated that adhering to an FFR-guided regimen for multi-vessel disease is cost beneficial to the hospital and payers by reducing procedural costs ($5,332 vs. $6,007), lowering average length of hospitalization (3.4 days vs. 3.7 days), and reducing the number of drug eluting-stents necessary per patient (1.9 vs. 2.7). The data also showed that the implementation of FFR did not add time to the multi-vessel PCI procedure.

"Angiography alone does not tell the whole story, and can even be misleading," continued Burnett. "FFR is now a well validated and readily available tool, which can quickly guide physicians to ischemia producing lesions that benefit most from stent placement. The number of multi-vessel disease cases worldwide is significant, and if adopting FFR can both improve patient outcomes and reduce hospital costs, we belie
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