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FAME 2 Published in the New England Journal of Medicine, Volcano participates in the $84M NIH-Sponsored ISCHEMIA Trial
Date:8/28/2012

is important because it shows COURAGE and angiography alone are not enough.  FAME 2 demonstrates that when deciding between OMT and interventional therapy you need to know if there is ischemia.  This will help lead to the right therapy for the right patient," commented Scott Huennekens, President & CEO of Volcano Corporation. "With the FAME 2 data in hand, and a few moments in the cath lab to perform FFR, interventional cardiologists can confidently say to their patients that PCI is the right personalized approach for them, and have the FFR value to prove it. Having the data now published in the New England Journal is a testament to the hard work of the investigators and the quality of the study design and execution."

FAME 2 showed that patients receiving PCI with proven ischemia by FFR had 66% fewer primary endpoint events including death, MI and urgent vascularization's than those patients treated with medical therapy alone (percentage of patients who had a primary endpoint event: 4.3% in the PCI group and 12.7% in the medical-therapy group; hazard ratio with PCI, 0.32; 95% confidence interval [CI], 0.19 to 0.53; P<0.001). The Registry arm also showed that patients with a negative FFR suggesting absence of ischemia did very well being treated with just medical therapy and no further intervention (primary endpoint event rate of 3.0%).

"The evidence continues to mount that using the physiology or the functional evaluation of a lesion is better than relying on angiography alone," added Joe Burnett, Executive Vice President and Physiology Business Unit Leader for Volcano. "We are all striving to improve outcomes and control costs at the same time, which means we need to make every device count. Tools available today like FFR and IVUS provide objective evidence to help make those critical decisions. Angiography guided PCI is giving way to Functional PCI to assess, guide and document each patient's unique episode of care. This is why we a
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SOURCE Volcano Corporation
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