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The HyperVue™ Imaging System - Integrated with compatible HyperVue™ Software and Starlight™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.

The Starlight Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.

The Starlight Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.

The NIRS capability of the HyperVue Imaging System - Integrated is intended for the detection of lipid core containing plaques of interest.

The NIRS capability of the HyperVue Imaging System - Integrated is intended for the assessment of coronary artery lipid core burden.

The NIRS capability of the HyperVue Imaging System - Integrated is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.

The HyperVue Imaging System – Integrated is a stationary, capital equipment platform intended for intravascular optical imaging of coronary arteries. HyperVue Imaging System – Integrated with the HyperVue Software and the Starlight Imaging Catheter is used as 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).

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