FDA Clears First Coronary OCT System in the United States


May 5, 2010
An optical coherence tomography (OCT) image of a stent in a coronary vessel. The shadows are from the stent struts.

Optical coherence tomography (OCT) offers high-definition intravascular imaging. LightLab Imaging's C7-XR OCT imaging system and companion C7 Dragonfly OCT imaging catheter offer near photographic quality visualization inside vessels.

The imaging system and catheter incorporate LightLab's Frequency Domain OCT (FD-OCT) technology. The system creates a 50 millimeter coronary scan in less than three seconds without the vessel occlusion that was required by earlier generation OCT systems introduced overseas. Thousands of data points are analyzed simultaneously at high speeds, providing intravascular resolution at 15 micrometers, roughly twice the size of a red blood cell. This nonocclusive, intravascular imaging technology allows the clinician to see and measure important vessel characteristics than might otherwise be difficult to visualize with intravascular ultrasound (IVUS).

The system catheter was cleared by the U.S. Food and Drug Administration (FDA) in May 2010.

For more information: www.lightlabimaging.com