Gentuity received FDA 510(k) clearance for its HF-OCT imaging system with the Vis-Rx micro-imaging catheter. Sudbury, Massachusetts-based Gentuity received approval for the technology for use both before and after percutaneous coronary intervention (PCI). The company said this makes it the only intravascular imaging platform specifically indicated for the assessment of the coronary vessel pre- and post-intervention.
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According to a news release, recent studies showed that pre-PCI imaging with OCT led to changes in procedural strategy of 80% of lesions. That includes lesion assessment (45%), vessel preparation strategy (27%), stent diameter (37%) and stent length (36%).
Building on this, Gentuity developed and commercialized its Vis-Rx micro-imaging catheter. The company says that, at 1.8 F, it represents the world’s smallest imaging platform. Its low crossing profile also enables essential pre-PCI imaging, reducing the need for pre-dilation. The system also streamlines the procedural workflow and enhances 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 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.
