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Volcano Completes Optical Coherence Tomography Cases, Plans To Use In US, South America

Volcano has completed optical coherence tomography (OCT) cases with its second generation OCT catheter and system. With pending IDE approval, Volcano plans to use the OCT system in the US and South America as part of VOILA, a US regulatory trial during 2010.

Volcano’s integrated OCT platform is expected to be built around the High-Definition Swept Source (HDSS), a non-laser light source from Axsun Technologies, a wholly-owned Volcano subsidiary. The HDSS has been tested at speeds which will translate into ultra-fast imaging and faster pullbacks for the physician.

The commercial release of Volcano’s OCT system is expected in Europe in early 2011 and in the US in mid-2011.

Scott Huennekens, president and chief executive officer of Volcano, said: “St Jude Medical’s acquisition of LightLab confirms the validity and potential utility of this technology. We are planning a best-in-class OCT solution. We currently have CE Mark in Europe on our first generation platform, and we are targeting a release of our second generation platform in Europe early next year.

“We anticipate that this system will incorporate a smaller catheter, shorter prep time, faster pullback speed, and a longer imaging segment than the current device.”

Michel Lussier, group president for advanced imaging systems, scientific affairs, and Volcano Europe, Africa, and the Middle East (EAME), said: “OCT is one of these new tools, like FFR and intravascular ultrasound (IVUS), that can help answer many of the questions left unclear by a two-dimensional x-ray image. OCT provides ultra-high resolution images of the vessel lumen and structural detail not seen before by other imaging modalities.

“With OCT, physicians will be able to visualise structures in the lumen and the adjacent vessel wall down to a resolution of approximately 15 microns. We believe the high resolution images that OCT provides along with the wider field of view, image depth, and plaque characterization that IVUS delivers will complement each other as physicians focus on lesion assessment and therapy guidance.”