LightLab Imaging gets FDA clearance for OCT imaging system and Dragonfly catheter

Westford, MA--LightLab Imaging, developer of optical coherence tomography (OCT) technology for vascular and other imaging applications, 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 (see also recent news, "Tomophase receives seventh patent for OCT fiber-optic imaging catheter".

The C7-XR Imaging System and the sleek, monorail-style C7 Dragonfly Imaging Catheter create a high resolution 50 mm 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 ultrahigh speeds, providing intravascular resolution at 15 micrometers, roughly twice the size of a red blood cell. LightLab Imaging says this 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.

"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 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.

--Posted by Gail Overton; [email protected]; www.laserfocusworld.com.