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FDA Clears LightLab Imaging C7-XR Coronary OCT Products In US

LightLab Imaging, a developer of optical coherence tomography (OCT) technology for vascular and other imaging applications, has received FDA clearance for the C7-XR Imaging System and companion C7 Dragonfly Imaging Catheter.

The products, incorporating LightLab Imaging’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 hospitals to perform high resolution imaging of vessel and lumen morphology in thousands of coronary interventions to date.

LightLab claimed that 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.

The data points are analyzed simultaneously at ultra-high speeds, providing intravascular resolution at 15 micrometers, roughly twice the size of a red blood cell. The 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.

Ik-Kyung Jang, principal investigator of US clinical study at LightLab, said: “The C7-XR Imaging System represents a significant step forward for intracoronary imaging. 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.”

David Kolstad, CEO of LightLab Imaging, said: “LightLab has been delivering state-of-the art intracoronary OCT systems to hospitals outside the US for over 5 years. With our clearance by the FDA, US clinicians 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 US clinicians. We will begin offering the C7-XR Imaging System and the C7 Dragonfly Imaging Catheter immediately.”