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LightLab Imaging Announces FDA Clearance of C7-XR(TM) Coronary OCT Products in the United States
Date:5/5/2010

WESTFORD, Mass., May 5 /PRNewswire/ -- LightLab Imaging, Inc., the pioneer and leader in the development of Optical Coherence Tomography (OCT) technology for vascular and other imaging applications, has received clearance from the U.S. Food and Drug Administration (FDA) for the C7-XR Imaging System and companion C7 Dragonfly Imaging Catheter. These products, incorporating LightLab's latest generation Frequency Domain OCT (FD-OCT™) technology, are currently approved in over 35 countries in Europe and Asia, and have been used by leading hospitals to perform high resolution imaging of vessel and lumen morphology in thousands of coronary interventions to date.

The C7-XR Imaging System and the sleek, monorail style C7 Dragonfly Imaging Catheter create a high resolution 50 millimeter coronary scan in under 3 seconds without the vessel occlusion that was required by earlier generation OCT systems.  Thousands of data points are analyzed simultaneously at ultra-high speeds, providing unsurpassed intravascular resolution at 15 micrometers, roughly twice the size of a red blood cell. This breakthrough, non-occlusive, intravascular imaging technology allows the clinician to readily see and measure important vessel characteristics otherwise invisible or difficult to observe with older intracoronary imaging modalities.

"The C7-XR Imaging System represents a significant step forward for intracoronary imaging," said Dr. Ik-Kyung Jang, M.D., Ph.D., Professor of Medicine at Harvard Medical School; Director, Cardiology Laboratory for Integrative Physiology and Imaging; physician at Massachusetts General Hospital, Boston, MA; and principal investigator for LightLab's U.S. clinic
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SOURCE LightLab Imaging, Inc.
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