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Volcano Receives CE Mark For OCT Imaging System, Catheter

OCT product line to complement its existing line of IVUS imaging catheters for coronary imaging and lesion assessment

Volcano, a developer and manufacturer of products for the diagnosis and treatment of coronary and peripheral artery disease, has received CE mark for its Optical Coherence Tomography (OCT) imaging system and catheter.

The company’s OCT product line is expected to complement its existing line of IVUS imaging catheters and pressure guide wires used for coronary imaging and lesion assessment.

Vince Burgess, president of Advanced Imaging Systems at Volcano, said: “This is a milestone in our development of OCT and highlights the progress of our OCT program overall. Volcano acquired its initial OCT technology through the acquisition of CardioSpectra, in December 2007.

“Since that time, the Volcano OCT system has generated positive results in numerous clinical studies in Europe and South America. Building upon the CE mark and pending IDE approval, Volcano plans to use this system in the US and South America as part of a US regulatory trial during 2010. We currently expect commercial release of our first OCT system in Europe in early 2011.”

Scott Huennekens, president and chief executive officer of Volcano, said: “Volcano is committed to expanding our technology leadership in intravascular imaging, both to complement everyday PCI (percutaneous coronary intervention) technique, and to further the understanding of atherosclerotic disease progression.

“We are working on products that incorporate OCT functionality into our s5i integrated platform, as well as stand-alone OCT systems. Our emphasis continues to be focused around providing a variety of therapy enabling modalities so that the physician can select which technology is most appropriate for each individual patient.”