Genuity has secured FDA 510(k) clearance for its HF-OCT (High-Frequency Optical Coherence Tomography) imaging system, incorporating the Vis-Rx micro-imaging catheter, marking a significant advancement in coronary intervention technology. This approval allows for the system's use both before and after percutaneous coronary intervention (PCI), offering clinicians enhanced capabilities for assessing coronary vessels.
The Gentuity system stands out as the only intravascular imaging platform specifically indicated for coronary vessel assessment both pre- and post-intervention. Recent studies have demonstrated that pre-PCI imaging with OCT led to changes in procedural strategy in 80% of lesions, including lesion assessment (45%), vessel preparation strategy (27%), stent diameter (37%), and stent length (36%).
The Vis-Rx micro-imaging catheter, developed and commercialized by Gentuity, is noted for its minimal size at 1.8 F, making it the world’s smallest imaging platform. This low crossing profile facilitates essential pre-PCI imaging, reducing the necessity for pre-dilation. The system also streamlines procedural workflow and enhances intervention accuracy by enabling 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 pre-dilation—offers clinicians unparalleled opportunities to optimize 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."
Nipro serves as the global distribution partner for Gentuity.
