Massachusetts-based Gentuity has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) Imaging System.
The imaging system, combined with the Vis-Rx Micro-Imaging Catheter, is now approved for use before and after percutaneous coronary intervention (PCI).
This approval makes the Gentuity HF-OCT Imaging System the only intravascular imaging platform specifically indicated for assessing coronary vessels pre-and post-intervention.
Its first human use occurred in January 2023 at St. Michael’s Hospital in Canada.
Gentuity has developed and commercialised the Vis-Rx Micro-Imaging Catheter as the world’s smallest imaging platform, measuring at 1.8 F.
According to the intravascular imaging technologies firm, the smallest imaging catheter’s low crossing profile allows for essential pre-PCI imaging, reducing the need for pre-dilation.
This streamlines the procedural workflow and enhances accuracy, enabling clinicians to assess coronary arteries in their native state.
Designed for pre- and post-intervention use, the Vis-Rx Imaging Catheter integrates advanced artificial intelligence (AI)-driven software. This allows physicians to access real-time, actionable insights in as little as one second, enhancing decision-making and improving procedural efficiency while minimising contrast use.
Additionally, pre-PCI imaging with OCT enhances procedural planning, reduces major adverse cardiovascular events (MACE), and improves stent deployment.
Gentuity president Desmond Adler said: “We are excited to receive this FDA clearance, which marks a major milestone for the Gentuity HF-OCT Imaging System.
“The ability to image pre-PCI where it is most needed, without pre-dilation, offers clinicians unparalleled opportunities to optimise treatment plans and obtain previously unavailable insights throughout the entire procedure.
“Combined with our AI-guided analysis tools, best-in-class scan range for left main and bifurcation assessment, and seamless device setup, the Gentuity HF-OCT Imaging System is truly an indispensable tool for advancing patient care.”
Gentuity is a commercial-stage medical technology company with a global presence. It develops next-generation intravascular imaging devices.
The company aims to enhance patient care, improve outcomes, and expand the use of intravascular guidance tools in cardiovascular disease.