Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)

The Cornaris Intravascular Imaging System (two cart models: P80-E and Mobile-E) is an ultrasonic optical coherence tomography (OCT) imaging system for visualizing coronary arteries during minimally invasive interventional procedures. The LumenCross Imaging Catheter (F2) is a single-use catheter compatible with the Cornaris system, designed for vessels 2.0–3.5 mm in diameter and explicitly contraindicated for the left main coronary artery or previously bypassed vessels.

The Cornaris system operates via the same optical imaging mode, system components, optical parameters, image display, and software features as the predicate ILUMIEN OPTIS. The LumenCross catheter shares the same outer diameter, working length, compatible guidewire, guidewire lumen length, radiopaque markers, purge mechanism, and single-use sterilization (ethylene oxide) as the predicate DRAGONFLY OPTIS imaging catheter. Differences include different cart dimensions/weight, visible laser parameters, pullback characteristics, and catheter-specific mechanical properties.

ISO 10993-1 biocompatibility testing framework, including cytotoxicity, sensitization, bacterial reverse mutation, acute systemic toxicity, hemolysis, and thrombogenicity assays. Performance testing evaluated against product specifications and known standards for scan range, axial resolution, luminous sensitivity, frame rate, fiber optic rotary joint characteristics, and catheter mechanical properties (bond strength, flexibility, corrosion, endotoxin).

The imaging core of Cornaris is technologically identical to ILUMIEN OPTIS in mode of operation, components, optical parameters, display, and software; physical and performance differences (cart design, laser visibility, pullback speed) do not affect imaging function. The LumenCross catheter is mechanically and functionally equivalent to DRAGONFLY OPTIS in critical specifications (diameter, length, guidewire compatibility, sterilization); pre-clinical animal studies and biocompatibility testing showed no significant differences from predicate. Both the system and catheter indication remains the same—coronary artery imaging for transluminal intervention in appropriately sized vessels—with established exclusions preserved.