Volcano nets 510(k) for intravascular ultrasound option

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Volcano, a manufacturer of intravascular ultrasound (IVUS) and functional measurement (FM) technology, has received the FDA 510(k) clearance of the s5-Revo and s5-fractional flow reserve (FFR) options.

The two new product offerings 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, the company said.

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 one platform, Volcano said.