Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
Gentuity, LLCThe Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter is a medical imaging device designed to provide high-resolution, real-time images of coronary arteries in patients undergoing transluminal interventional procedures. It uses near-infrared light delivered via a fiber-optic catheter to visualize coronary tissue, aiding clinicians in diagnosis and treatment planning.
Intended Use
The Gentuity® HF-OCT Imaging System with Vis-Rx® Prime Micro-Imaging Catheter is intended for intravascular imaging and is indicated for use in coronary arteries in patients who are candidates for transluminal interventional procedures.
Technology
The system includes an imaging console with an optical engine and probe module, a single-use micro-imaging catheter delivering near-infrared light via fiber-optics to coronary arteries, and an optional review station for image analysis. The catheter is designed for vessels 1.3 to 6.0 mm in diameter and uses a rotating optical fiber and lens assembly to capture reflected light and produce high-resolution images.
Performance
Performance testing included bench testing, animal studies under GLP, biocompatibility testing per ISO 10993-1 standards, particulate and coating integrity assessments, and sterilization validation. Results met applicable acceptance criteria.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/26/2024
4 months - 2
FDA Approval
1/31/2025
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