LightLab Imaging Announces
FDA Clearance of
C7-XR(TM) Coronary OCT Products
in the United States
LightLab's C7-XR Imaging System and C7 Dragonfly(TM) Imaging Catheter become first OCT products available to U.S. interventional cardiologists for intracoronary imaging
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May 5, 2010 -- Westford, Mass. --
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.
About LightLab Imaging, Inc.
LightLab Imaging, Inc., based in Westford MA, is the world's leading
manufacturer and marketer of Optical Coherence Tomography (OCT) for
vascular and other imaging applications. LightLab's OCT systems and
imaging catheters are cleared for sale in 40 countries in Europe, Asia,
the Middle East and North and South America. The company was founded
in 1998 by the inventors of OCT, and has exclusive license to a broad
range of OCT technologies and applications from MIT and
other entities. The LightLab mission is to develop and distribute photonic
imaging technologies that improve patients' wellbeing, enhance diagnostic
medicine, improve outcomes, and reduce healthcare expenditures. With
the ability to resolve real-time images to 15 micrometers, the LightLab
Imaging OCT Imaging Systems offer physicians more precise information
than ever before. For more information, visit www.lightlabimaging.com.
About LightLab OCT
LightLab Optical Coherence Tomography (OCT)
is the Extreme Resolution™ imaging technology for cardiovascular
disease diagnosis. LightLab OCT utilizes near-infrared light to create
images with 10 times the resolution of Intravascular ultrasound (IVUS).
LightLab OCT is a radiation-free* imaging system. The
proprietary LightLab OCT interferometer analyzes reflected light
waves to create our extreme resolution Golden Image™ for enhanced
diagnosis and treatment decisions. *OCT is not a source of ionizing radiation, such as X-rays.
Source: LightLab Imaging, Inc.
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