Gentuity has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for its Gentuity HF-OCT imaging system, featuring the Vis-Rx Micro-imaging catheter.
According to Gentuity, the imaging system is designed for use both before and after percutaneous coronary intervention (PCI), making it the only intravascular imaging platform specifically indicated for the assessment of the coronary vessel pre and post intervention.
Gentuity has developed and commercialised the Vis-Rx Micro-imaging catheter—a 1.8Fr catheter that the company describes as the world’s smallest imaging platform. The low crossing profile of the Vis-Rx Micro-imaging catheter makes it capable of performing 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.
“We are excited to receive this FDA clearance, which marks a major milestone for the Gentuity HF-OCT imaging system,” said Desmond Adler, president of Gentuity. “The ability to image pre-PCI where it is most needed—without predilation—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.”
Hiram Bezerra (Tampa General Hospital, Tampa, USA) said: “The expanded indication for the Gentuity HF-OCT imaging system, particularly for pre-PCI imaging, represents a major step forward in coronary intervention. The ability to assess coronary arteries comprehensively before and after intervention enhances procedural planning and post-procedural assessment, ultimately improving patient outcomes. The high-speed pullback, 100mm in one second, coupled with a very small catheter profile, 1.8Fr, position HF-OCT as the ideal system for pre-intervention imaging.”
