The SpectraWAVE Imaging System is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure by combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) in a single catheter-based system. The SpectraWAVE Imaging System consists of the following components:• Console: A mobile platform containing the optical and computing engine, physician and technologist touch displays, power distribution system, and input/output interface. • Software: A proprietary application software that orchestrates the control, acquisition, processing, and display of the OCT-NIRS data. • Catheter Interface Unit (CIU): A tethered CIU that controls the motion of the fiber optic imaging core within the Catheter sheath and connects the Catheter to the Console.• Imaging Catheter: A sterile, single patient use 2.5 French dual-modality imaging catheter containing a rotating fiber optic imaging core inside a protective sterile sheath.
A fibreoptic flexible tube intended to be percutaneously introduced into the vasculature (e.g., peripheral vessels, coronary arteries) to perform near-infrared spectroscopy [NIRS] for intravascular examination, especially for detection and image-based quantification of lipid core plaques. Its proximal end connects to a parent spectroscopy system for the transmission of light signals for viewing and analysis. This is a single-use device.
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