LightLab Imaging of Westford, MA won FDA approval to market the C7-XR coronary imaging system that utilizes non-ionizing Frequency Domain Optical Coherence Tomography (FD-OCT) to visualize the vessel and lumen. The system, which uses the accompanying C7 Dragonfly Imaging Catheter to perform intravascular imaging, already received European regulatory approval and is now available essentially worldwide.
More about the system from LightLab:
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.
Highly automated procedure is fast and easy for enhanced throughput and productivity Extreme resolution displays important information beyond the resolution of IVUS to optimize treatment strategies Automated analysis measurement functions improve understanding and simplify complex therapeutic decisions Capable of visualizing and measuring a wide range of materials and structures for tailored therapies Works with the C7 Dragonfly™ Imaging Catheter
Demo video and links below the fold:
Press release: LightLab Imaging Announces FDA Clearance of C7-XR™ Coronary OCT Products in the United States….
Product page: C7-XR Coronary Imaging System…