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Cornaris Intravascular Imaging System with Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. LumenCross Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. The LumenCross Imaging Catheter (referred to as LumenCross) with the Cornaris Intravascular Imaging System produced by Vivolight, which is intended for intravascular imaging and is indicated for use in coronary arteries in patients who are candidates for transluminal interventional procedures. The LumenCross intended for use in vessels 2.0~3.5mm in diameter. The LumenCross is not indicated for use in the left main coronary artery or in a target vessel that has undergone a previous bypass procedure.

Cornaris Intravascular Imaging System are cart-mounted computer and Imaging Engin(or optical engine) placed inside an ergonomically designed mobile cart with the cable underground. There are two models, P80-E is mainly composed of trolley, mouse, keyboard, two display monitors, optical engine, computer. Mobile-E is mainly composed of trolley, mouse, keyboard, one display monitor, monitor bracket, optical engine, computer. The both also includes the catheter connection unit (PIU), which provides the interconnection between the Cornaris Intravascular Imaging System and the LumenCross Imaging Catheter.P80-E and Mobile-E has the same software features. The imaging catheter contains two main components: the catheter body and imaging core (internal rotating fiber optic). The outer diameter of the distal shaft of the catheter was 2.67 F (0.89 mm, 0.035 in.), and the length of the distal shaft was 280mm. The imaging catheter has a working length of 1350mm. The imaging catheter is compatible with 0.014" (0.356 mm) guidewire, which with a guidewire lumen length of 16 mm, the guidewire enters through tip entrance and exit through the RX port. The hydrophilic coating is applied on the outer surface of distal shaft. The LumenCross Imaging Catheter is a single use device. The LumenCross Imaging Catheter is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of two years.