The catheter-based imaging system offers real-time two- and four-dimensional views to enhance precision and confidence in cardiac procedures.
LUMA Vision Ltd, a provider of cardiac imaging and navigation, announced the US Food and Drug Administration clearance of its Verafeye visualization platform, a catheter-based imaging system that provides real-time two- and four-dimensional, 360-degree visualization.
The Verafeye system combines 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, according to a release from the company.
Traditional imaging catheters provide only two-dimensional imaging, often limiting clinicians’ ability to view cardiac anatomy from all angles during procedures.
“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,” says Fionn Lahart, CEO at LUMA Vision, in a release.
The system is prepared for magnetic tracking and navigation of third-party catheters.
“Our clinical experience with Verafeye is exciting, with the potential to simplify procedural workflow and efficiency,” says Shephal Doshi, MD, director of electrophysiology at Pacific Heart Institute/Cedars Sinai and investigator of the Verafeye system, in a release. “Real-time visualization and rapid creation of cardiac anatomy can facilitate de novo procedures with greater simplicity.”
ID 360122416 | Heart © Midhun Menon | Dreamstime.com
