Navigation Links
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. 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.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. LightLab Highlights OCT Market Leadership at the Society for Cardiovascular Angiography and Interventions
2. Date Set for LightLab Damages Trial Against Volcano and Axsun
3. Epix Pharmaceuticals, Inc. Announces the May 28, 2010 Auction Sale of EP-3600 MRI Imaging Agent
4. Alliance Imaging Offers Mobile Positron Emission Mammography (PEM) Imaging to its Florida Customers
5. Water Street Healthcare Partners Signs Definitive Agreement to Sell Sierra Scientific Instruments to Given Imaging
6. ChemImages Raman Chemical Imaging Used for Ingredient-Specific Particle Sizing for Inhalation Product Development
7. VisEn Launches New VivoTag(R) 680 XL Fluorescence Molecular Imaging Label
8. InfraReDxs LipiScan(TM) Coronary Imaging System for Identification of Lipid Core Plaque to be Highlighted at 59th Annual Scientific Session of the American College of Cardiology
9. Rcadia Medical Imaging’s COR Analyzer(R) System Receives CE Mark
10. Rapid Review Imaging System From P&R Dental Strategies Assures Fast, Accurate and Efficient Dental Claim Review
11. Pro Medicus/Visage Imaging Signs Deal with Sydney-based Southern Radiology
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... , June 24, 2016 The Academy of ... recommendations that would allow biopharmaceutical companies to ... entities that make formulary and coverage decisions, a move ... of new medicines. The recommendations address restrictions ... appear on the drug label, a prohibition that hinders ...
(Date:6/24/2016)... , June 24, 2016   Pulmatrix, Inc ... company developing innovative inhaled drugs, announced today that it ... Russell Investments reconstituted its comprehensive set of U.S. ... "This is an important milestone for Pulmatrix," said ... increase shareholder awareness of our progress in developing drugs ...
(Date:6/23/2016)... , June 23, 2016 Any dentist who ... challenges of the current process. Many of them do not ... the technical difficulties and high laboratory costs involved. And those ... offer it at such a high cost that the majority ... Dr. Parsa Zadeh , founder of Dental ...
Breaking Medicine Technology:
(Date:6/25/2016)... Long Beach, CA (PRWEB) , ... June 25, 2016 , ... ... from UCLA with Magna Cum Laude and his M.D from the David Geffen School ... San Diego and returned to Los Angeles to complete his fellowship in hematology/oncology at ...
(Date:6/25/2016)... ... ... On Friday, June 10, Van Mitchell, Secretary of the Maryland Department of ... recognition of their exemplary accomplishments in worksite health promotion. , The Wellness at Work ... Symposium at the BWI Marriott in Linthicum Heights. iHire was one of 42 businesses ...
(Date:6/24/2016)... ... 24, 2016 , ... A recent article published June 14 on ... article goes on to state that individuals are now more comfortable seeking to undergo ... such as calf and cheek reduction. The Los Angeles area medical group, Beverly Hills ...
(Date:6/24/2016)... Marne, Michigan (PRWEB) , ... June 24, 2016 , ... ... awareness about the dangers associated with chronic pain and the benefits of holistic treatments, ... for individuals who are suffering with Sickle Cell Disease. , Sickle Cell Disease (SCD) ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary ... Dallas that it will receive two significant new grants to support its work ... marked its 25th anniversary by recognizing patients, medical professionals and scientists for their ...
Breaking Medicine News(10 mins):