Dublin, Ireland–based Luma Vision said the study aims to, in part, evaluate the ability of its Verafeye 4D navigation and imaging platform. The company designed Verafeye to guide catheter ablation therapy. That includes pulmonary vein isolation, posterior wall isolation and ablation of the cavotricuspid isthmus.
Verafeye won FDA clearance in April 2025.
The study evaluated Verafeye’s capabilities using the CardioFocus QuickShot Nav pulsed field ablation (PFA) catheter system. Marlborough, Massachusetts-based CardioFocus designed QuickShot Nav to support safe, effective and efficient pulmonary vein isolation (PVI) ablation workflows with fewer applications required to achieve flexible lesion sets. It features a magnetic navigation sensor to facilitate compatibility with magnetically enabled electroanatomic mapping systems.
QuickShot Nav also utilizes CardioFocus’ patented PFA waveform, Wave 1. The large-area, focal map-and-ablate catheter delivers rapid, effective PFA lesions, including in areas of thick tissue. CardioFocus announced the start of a trial for the technology in November.
The completed 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, Luma Vision said. This approach provided real-time, 4D visualization of the beating heart for two-catheter ablation.
Luma Vision said it enables the combination of AI-driven anatomical modeling with automatic catheter tracking and guidance. This could deliver enhanced planning, execution and verification for AFib ablation.
Fionn Lahart, CEO of Luma Vision, said:
“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. 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.”
