Volcano has received FDA 510(k) clearance for the s5-Revo and s5-FFR or fractional flow reserve options.
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These two new product offerings now enable rotational IVUS and FFR to operate on the same integrated Volcano s5 Imaging System as Volcano’s previous line of phased array IVUS catheters and functionality.
Scott Huennekens, president and CEO of Volcano, said: “By adding high resolution rotational IVUS and pressure-based FFR to our already highly successful phased array s5 imaging platform, we will be providing a level of technology, clinical utility and convenience that is un-matched in the intravascular imaging field.”
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