Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)
Shenzhen Vivolight Medical Device & Technology Co., Ltd.The Cornaris Intravascular Imaging System (P80-E and Mobile-E) with the LumenCross Imaging Catheter (F2) is an advanced intravascular imaging system designed to help clinicians visualize coronary arteries during transluminal interventional procedures. It uses optical coherence tomography technology to provide high-resolution images of the inside of blood vessels, aiding in diagnosis and treatment planning for patients with coronary artery conditions. The system enhances the ability to assess blood vessels safely and effectively, improving patient outcomes.
Intended Use
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.
Technology
The system consists of a cart-mounted computer and imaging engine with two models (P80-E and Mobile-E). It uses an internal rotating fiber optic imaging core to acquire OCT images via imaging catheter. The catheter includes a guidewire lumen and hydrophilic coating for intravascular navigation.
Performance
Performance testing included scan range, axial resolution, frame rate, sensitivity, dynamic range, pullback time, and fiber optic joint performance. The catheter was tested visually and dimensionally, and subjected to biological safety testing including cytotoxicity, sensitization, and in vivo thrombogenicity. Animal studies demonstrated safety and equivalence to predicate devices. No clinical study included.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/18/2024
8 months - 2
FDA Approval
4/11/2025
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