LightLab Receives FDA Clearance for C7-XR Imaging System

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. clinical study. "We were all amazed with the speed and simplicity of the LightLab OCT procedure, and the clinical utility is truly unique. I expect OCT to rapidly become the new intracoronary imaging standard."

"LightLab's C7-XR FD-OCT image resolution is extraordinary, but what is most fascinating about this technology is its ease of use and extremely fast image acquisition," said Dr. Marco Costa, MD, Ph.D., Professor of Medicine; Director, Interventional Cardiovascular Center; and Director, Center for Research and Innovation Harrington-McLaughlin Heart and Vascular Institute University Hospitals, Case Western Reserve University. "These features will enable optimization of drug-eluting stent procedures with unprecedented accuracy, potentially reducing the number of stents placed per patient by ensuring appropriate disease assessment and targeting. The physician armed with OCT will have the ability to see the lumen vividly from the inside giving us incredible information and the ability to treat sub-optimal results while the patient is still in the cath lab."

"LightLab has been delivering state-of-the art intracoronary OCT systems to leading hospitals outside of the United States for over 5 years," said David Kolstad, CEO of LightLab Imaging. "With our clearance by the FDA, U.S. clinicians now have access to a fast and easy-to-use, high-resolution imaging system. We believe C7-XR Imaging System and C7 Dragonfly Imaging Catheter will enhance the diagnostic information and procedural control available to U.S. clinicians. We will begin offering the C7-XR Imaging System and the C7 Dragonfly Imaging Catheter immediately."

LightLab Imaging will demonstrate the C7-XR Imaging System and C7 Dragonfly Imaging Catheter in booth number 28 at the Society for Cardiovascular Angiography and Interventions' 2010 Scientific Sessions in San Diego, from May 5 to 8.

LightLab's U.S. clinical study of the C7-XR Imaging System and C7 Dragonfly Imaging Catheter was conducted at three U.S. centers. The centers and the investigators were:

• Massachusetts General Hospital: Ik-Kyung Jang, M.D., Ph.D.
• Columbia University Presbyterian Hospital: Jeffrey Moses, M.D., FACC, Giora Weisz, M.D., George Dangas M.D., Ph.D., and Varinder Singh, M.D.
• Stanford University Medical Center: William Fearon, M.D. and Alan Yeung, M.D.

The core laboratory responsible for analyzing the study results was:

• University Hospitals Case Medical Center-Interventional Cardiovascular Center and Research & Innovation Center: Marco Costa M.D., Ph.D. and Hiram G. Bezerra, M.D., Ph.D.