FDA clears LightLab's coronary OCT technology
The FDA has approved LightLab Imaging's coronary optical coherence tomography (OCT) products, the C7-XR imaging system and C7 Dragonfly imaging catheter, used to obtain high-resolution images of the vessels and lumen morphology during intracoronary imaging.
According to Westford, Mass.-based LightLab, the C7-XR and C7 Dragonfly can obtain a 50 mm coronary scan in less than three seconds without requiring vessel occlusion like previous generations of OCT technology.
Additionally, the company said that the technology, through fast image acquisition, can analyze thousands of data points and provides intravascular resolution at 15 mm.
The company said the technology will aid in increased accuracy during drug-eluting stent procedures due to its capabilities to better assess disease and stent placement.
The systems have previously gained approval by the EU for its use in 35 countries throughout Europe and Asia.
According to Westford, Mass.-based LightLab, the C7-XR and C7 Dragonfly can obtain a 50 mm coronary scan in less than three seconds without requiring vessel occlusion like previous generations of OCT technology.
Additionally, the company said that the technology, through fast image acquisition, can analyze thousands of data points and provides intravascular resolution at 15 mm.
The company said the technology will aid in increased accuracy during drug-eluting stent procedures due to its capabilities to better assess disease and stent placement.
The systems have previously gained approval by the EU for its use in 35 countries throughout Europe and Asia.