FDA Clears LightLab's C7-XR Coronary OCT Imaging System

May 5, 2010—LightLab Imaging Inc. (Westford, MA) announced that it has received clearance from the US Food and Drug Administration (FDA) for the C7-XR optical coherence tomography (OCT) imaging system and the companion C7 Dragonfly imaging catheter. These products incorporate LightLab's latest-generation frequency domain OCT (FD-OCT) technology to provide high-resolution imaging of vessel and lumen morphology in coronary interventions.

The C7-XR imaging system and the monorail-style C7 Dragonfly imaging catheter create a high-resolution 50-mm coronary scan in less than 3 seconds without vessel occlusion. Thousands of data points are analyzed simultaneously at ultrahigh speeds, providing intravascular resolution at 15 µm. This nonocclusive, 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 company stated.

According to the company, LightLab OCT is a radiation-free imaging technology for cardiovascular disease diagnosis. It uses near-infrared light to create images with 10 times the resolution of intravascular ultrasound. The device's interferometer analyzes reflected light waves to create LightLab's extreme resolution golden image for enhanced diagnosis and treatment decisions.

“The C7-XR Imaging System represents a significant step forward for intracoronary imaging,” commented Ik-Kyung Jang, MD, who served as principal investigator for LightLab's United States 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.”

Marco Costa, MD, who conducted the core laboratory analysis, added, “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. 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. With OCT, the physician will have the ability to see the lumen vividly from the inside, giving incredible information and the ability to treat suboptimal results while the patient is still in the catheterization lab.”