#USA #Dublin #Cardiac Imaging #LUMA Vision #VERAFEYE

Introduction

LUMA Vision Ltd., recognized as a trailblazer in the field of cardiac imaging and navigation, has achieved FDA clearance for its latest innovation—the VERAFEYE™ Visualization Platform. This robust system represents a revolutionary advancement in medical imaging technology, specifically tailored for the complexities of electrophysiology and structural heart procedures.

What Makes VERAFEYE Unique?

The VERAFEYE system is an innovative catheter-based imaging system that offers real-time, two-dimensional (2D) and four-dimensional (4D) imaging with a comprehensive 360-degree perspective. This remarkable visualization capability significantly boosts the accuracy and confidence of clinicians performing intricate cardiac procedures. By integrating magnetic tracking and navigation of third-party catheters, the system is poised to further enhance procedural precision and control over time.

Highlights of the Technology

One of the standout features of the VERAFEYE system is its ability to provide high-resolution images from distances up to 120 mm away from the catheter. This depth and clarity are crucial for clinicians during cardiac procedures, allowing them to navigate the heart's anatomy in real time. Unlike traditional imaging catheters that only provide limited 2D views, VERAFEYE reshapes the landscape of intracardiac imaging by delivering dynamic, 360-degree visuals.

Dr. Shephal Doshi, Director of Electrophysiology at Pacific Heart Institute/Cedars Sinai and a key investigator for the VERAFEYE technology, emphasized its potential impact on procedural efficiency. He noted, "Real-time visualization and rapid creation of cardiac anatomy can facilitate de novo procedures with greater simplicity."

Implications of the Approval

The FDA's approval of the VERAFEYE system marks a significant leap forward for the medical community in enhancing procedural workflows. Fionn Lahart, the CEO of LUMA Vision, expressed enthusiasm for how this technology can address a variety of cardiac challenges, including cardiac arrhythmias and structural heart issues. Lahart stated, "We are incredibly proud of this achievement and the potential impact VERAFEYE will have… This FDA clearance is a testament to our team's dedication and expertise."

A New Era in Cardiac Imaging

The VERAFEYE system is not just a step up in imaging quality; it represents a fundamental shift in how clinicians can approach cardiac navigation. By providing real-time volumetric images of the heart alongside magnetic navigation, clinicians can make informed decisions more efficiently, ultimately serving to reduce both the procedure time and the overall risks involved.

Dr. Anish Amin, System Medical Chief for Cardiac Electrophysiology at OhioHealth Heart and Vascular, endorsed its capabilities, referring to it as a necessary path forward in precision imaging that lays a solid foundation for elevating care standards further.

About LUMA Vision

Headquartered in Dublin, Ireland, and Munich, Germany, LUMA Vision is dedicated to bridging significant clinical needs with innovative technological solutions. Their commitment lies in creating groundbreaking products that enhance patient care and clinical outcomes internationally. The VERAFEYE™ platform underscores this mission, offering a novel cardiac visualization and navigation approach that fundamentally improves how healthcare providers interact with cardiac structures.

For more information about LUMA Vision and the VERAFEYE platform, visit www.lumavision.com.