Volcano receives FDA clearance for digital IVUS catheter and CE Mark for OCT system

San Diego, CA—Volcano Corp. (VOLC) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Eagle Eye Platinum digital IVUS catheter in the United States. Compared to its predecessor, the Eagle Eye Gold, this version offers improved deliverability and additional radiopaque markers. Commercial release is expected in the second quarter.

Vince Burgess, group president for Advanced Imaging Systems for Volcano, remarked, “Although IVUS has been the gold standard for objective measurements of lumen size, plaque composition, and stent expansion, many regular IVUS users still do not use IVUS to make lesion length assessments. Eagle Eye Platinum’s radiopaque markers should provide a quick and easy way for physicians to estimate lengths without the need for a separate pullback device. We believe that this new feature along with the deliverability improvements will increase usage among physicians, allowing for more precision and accuracy in treating blood vessel blockages.”

In January the company announced receipt of CE mark for its Optical Coherence Tomography (OCT) imaging system and catheter. Burgess reports that, “Building upon the CE mark and pending IDE approval, Volcano plans to use this system in the U.S. and South America as part of a U.S. regulatory trial during 2010. We currently expect commercial release of our first OCT system in Europe in early 2011.”