Luma Vision has announced the successful completion of 15 Verafeye-guided persistent atrial fibrillation (AF) ablation procedures conducted as part of a clinical study in collaboration with Cardiofocus.
The study is designed, in part, to evaluate the ability of Luma Vision’s Verafeye 4D navigation and imaging platform to completely guide catheter ablation therapy, including pulmonary vein isolation (PVI), posterior wall isolation and ablation of the cavotricuspid isthmus using the Cardiofocus QuickShot Nav pulsed field ablation (PFA) catheter system.
Completion of the procedures demonstrated Verafeye’s ability to integrate high-resolution intracardiac imaging—2D and 4D—and navigation with automatically generated digital anatomy of both atria from a right atrial acquisition. This approach provided clinicians with real-time, 4D visualisation of the beating heart, enabling a streamlined two-catheter ablation workflow, improving precision and efficiency in complex procedures, according to Luma Vision. The company also claims in a press release that, by combining artificial intelligence (AI)-driven anatomical modelling with automatic catheter tracking and guidance, Verafeye is redefining how ablation procedures for both paroxysmal and persistent AF are planned, executed, and verified.
“Using an empirical lesion set is the preferred approach for de-novo AF ablation in the persistent population. The Verafeye system’s disruptive approach to 3D geometry creation allowed me to only use one catheter for imaging [2D ICE (intracardiac echocardiography)], navigation and rapid digital anatomy [RDA], which is unique in the market,” said Ante Anic (KBC Split, Split, Croatia). “When the Verafeye-created RDA is combined with a large-focal PFA platform like Cardiofocus QuickShot, operators have a perfect two-catheter toolset to deliver their preferred empirical lesion set, including linear ablation for beyond PVI, in less than an hour. This is the new definition of procedural efficiency.”
“Treating this initial patient cohort marks a pivotal moment for Luma Vision, and we are very thankful to our partners at KBC Split and Cardiofocus,” added Fionn Lahart, chief executive officer (CEO) of Luma Vision. “Our goal is to bring accuracy, efficiency and precision to cardiac procedures to help achieve positive patient outcomes. Driven by advanced machine learning and AI, Verafeye is a category-defining, powerful cardiac guidance platform that aims to provide a new standard of care in combination with integrated third-party devices and catheters. Today, we’ve proven Verafeye’s ability to guide AF therapy with unparalleled clarity and precision—and, in the future, it will enable interventions like left atrial appendage closure and structural heart procedures. The clinical impact will be profound, and we’re excited to bring this technology to a broader global market in 2026.”
Luma Vision states in its recent release that the results of the procedures highlight Verafeye’s potential to reduce procedure times, improve anatomical accuracy, and reduce complications, by providing clinicians with a real-time, accurate and interactive view of the heart in motion throughout ablation procedures.
