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Volcano Announces FDA 510(k) Clearance of Revolution Rotational Catheter and FFR for the s5i Integrated IVUS Console
Date:2/7/2008

ly one of the three technologies now available on the s5. If a hospital wanted to equip a new lab with all three technologies, they would have to acquire three separate consoles, each with a different measurement modality, training requirements and data storage protocols. The Volcano s5 can now accommodate the three primary intravascular diagnostic tools in regular use by cardiologists today (high frequency rotational IVUS, fast and simple digital IVUS, and pressure-based FFR guidewires) on a single platform, making modern day imaging consoles more flexible than ever before.

Joe Burnett, associate vice president of marketing for Volcano, said, "The past three years of engineering work have culminated in the launch of this product, and underline the concept of choice in the cardiac cath lab. The new s5 integrated product will appeal and offer choice to two distinct customer groups; First, for cath lab administrators who are trying to accommodate different physician preferences and practice patterns the Volcano s5 platform now offers all three primary technologies on one platform. As a result, cath lab managers can ensure their individual physician preferences are met with one system. Second, the Volcano system will appeal to physicians themselves, as they will now have three powerful diagnostic tools on one platform, all at-the-ready for their patients. If a physician wants a high resolution IVUS image to measure plaque burden, they can select a Revolution(TM) IVUS catheter. If they want a fast, simple IVUS image to assess stent placement, they can quickly plug in an Eagle Eye(R) Gold IVUS catheter. If they want to objectively measure lesion severity prior to committing to a therapeutic strategy, they can use a Volcano FFR guidewire. The ability to choose any or all of these technologies, and quickly implement them should the need arise, is a powerful message that has resonated well with our customers."

Training and Education

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