Device Dossier

Ilumien System - Coronary optical coherence tomography system

Device Dossier for Ilumien System - Coronary optical coherence tomography system (Coronary optical coherence tomography system, Class IIa, sponsor Abbott…

Intended purpose

The ILUMIEN System uses optical imaging catheters to produce high-resolution, real-time images that provide for both qualitative and quantitative evaluation of vascular morphology in the coronary arteries. The System can also determine Fractional Flow Reserve through radio frequency signals that are acquired from a distal intracoronary pressure transducer and proximal aortic pressure transducer.

TGA Public Summary