Gentuity HF-OCT imaging system receives FDA 510(k) clearance for Coronary Intervention Imaging  

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Gentuity, a global leader in advanced intravascular imaging technologies, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Gentuity HF-OCT Imaging System, featuring the Vis-Rx Micro-Imaging Catheter, for use both before and after percutaneous coronary intervention (PCI). It is the only intravascular imaging platform specifically indicated for the assessment of the coronary vessel pre and post intervention.
 

Gentuity has developed and commercialized the Vis-Rx Micro-Imaging Catheter, which at 1.8 F is the world's smallest imaging platform. The low crossing profile of the Vis-Rx Micro-Imaging Catheter enables to perform essential pre-PCI imaging, reducing the need for pre-dilation, streamlining the procedural workflow, and enhancing intervention accuracy by allowing clinicians to assess coronary arteries in their native state.

Key Benefits of the Gentuity HF-OCT Imaging System:

• Smallest Imaging Catheter: The 1.8 F Vis-Rx Micro-Imaging Catheter is the smallest intravascular imaging device in the world, designed with a low crossing profile to streamline image acquisition without the potential need for pre-dilation.
• Pre- and Post-Intervention Use: Designed to streamline workflow and enhance decision-making in PCI procedures, the Vis-Rx Imaging catheter, integrated with advanced AI-driven software, enables physicians to access real-time, actionable insights in as little as one second. The innovative system improves procedural efficiency while also minimizing contrast utilization.
• Improved Clinical Outcomes: Pre-PCI imaging with OCT has been shown to enhance procedural planning, reduce MACE, and improve stent deployment.