The VERAFEYE system combines state-of-the-art imaging technology with advanced digital maneuverability, enabling clinicians to capture highly detailed, four-dimensional images that update in real time. With imaging depths up to 120 mm away from the catheter, it allows for dynamic high-resolution navigation and visualization of the heart, crucial to performing today’s advanced electrophysiology and structural heart 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.

“Our clinical experience with VERAFEYE is exciting, with the potential to simplify procedural workflow and efficiency,” said Dr. Shephal Doshi, Director of Electrophysiology at Pacific Heart Institute/Cedars Sinai and investigator of the VERAFEYE system. “Real-time visualization and rapid creation of cardiac anatomy can facilitate de novo procedures with greater simplicity.”

Fionn Lahart, CEO, at LUMA Vision, expressed excitement about the technology’s potential: “We are incredibly proud of this achievement and the potential impact VERAFEYE will have in areas such as cardiac arrhythmias, left atrial appendage closure and structural heart. Our team and partners have worked tirelessly alongside clinicians to develop a product that can be the future of cardiac navigation, and this FDA clearance is a testament to their dedication and expertise. We look forward to seeing the positive difference VERAFEYE will make in the lives of patients and healthcare providers alike”.