LUMA Vision Successfully Completes First-in-Human Procedures with its Novel VERAFEYE™ Navigation and Visualization Platform

USA - English

• USA - English

DUBLIN, Jan. 14, 2025 /PRNewswire/ -- LUMA Vision Ltd., an innovative leader in Cardiac Navigation and Visualization technology, proudly announces the successful first-in-human use and enrollment in its LUMINIZE clinical study, using the groundbreaking VERAFEYE™ platform. This cutting-edge, four-dimensional catheter-based imaging system is designed to transform the field of interventional electrophysiology by providing unprecedented real-time visualization of the heart's chambers. The system magnetically tracks the navigation of 3^rd party catheters, empowering clinicians to perform complex procedures with greater precision and control.

The VERAFEYE™ system combines state-of-the-art imaging technology with advanced maneuverability, enabling clinicians to capture highly detailed, four-dimensional images that update in real time. This allows for dynamic high-resolution navigation and visualization of the heart, crucial to performing today's advanced electrophysiology procedures with a wide variety of technologies. Traditional imaging catheters provide only two-dimensional imaging, often limiting clinicians' ability to view cardiac anatomy from all angles during procedures. The VERAFEYE™ catheter introduces a new era of intracardiac imaging, allowing for comprehensive, 360-degree visualization with enhanced depth and clarity. This enables the VERAFEYE™ Rapid Digital Anatomy (RDA) feature which allows clinicians to build CT quality reconstructions of both atrial chambers in under 60 seconds.

The first procedures, performed at the Mater Private Network, Dublin under the guidance of leading Electrophysiologist Professor Gabor Széplaki, demonstrated the VERAFEYE™ systems potential to improve procedural workflows by enhancing accuracy, visualization, and control. Professor Széplaki commented on the significance of this achievement: "The VERAFEYE™ system provides a level of detail and real-time spatial context that is unmatched by traditional imaging methods. This innovative technology represents a major leap forward in our ability to deliver precise and effective treatments for patients with complex heart conditions. VERAFEYE™ has the ability to provide all the navigation and imaging needed during today's single shot procedures in one system."

The successful use of the VERAFEYE™ system represents a significant step toward improving procedural workflows, improving patient outcomes, and broadening the potential for many of the innovative technologies that need navigation to deliver effective treatment. By providing real-time, volumetric images of the heart, interactive visualization, and navigation of catheters, the VERAFEYE™ system enables clinicians to make more informed decisions, potentially reducing procedure time and minimizing risks.

Fionn Lahart, CEO at LUMA Vision, expressed excitement about the technology's potential: "We are thrilled by this milestone and the future possibilities it opens for cardiac care in areas such as cardiac arrhythmias, left atrial appendage closure and structural heart conditions. The development of VERAFEYE™ is a testament to our team's commitment to pushing the boundaries of medical technology and with imminent market approval, we can equip clinicians with the tools they need to achieve better outcomes for patients worldwide."

About LUMA Vision

LUMA Vision is a privately held, medical device company based in Dublin, Ireland and Munich, Germany. LUMA Vision designs and develops cutting edge innovative technologies to significantly advance healthcare and solve truly global unmet clinical needs. VERAFEYE™ is a novel ultrasound based cardiac visualization and navigation platform for generating a 360-degree view, imaging all structures and devices around the catheter with an unprecedented field of view. With a commitment to advancing patient care, LUMA Vision focuses on delivering groundbreaking products that enhance clinical outcomes and improve lives around the world. LUMA Vision was founded by CEO Fionn Lahart and Chief Technology Officer Christoph Hennersperger. Learn more about LUMA Vision and VERAFEYE™ at www.lumavision.com

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