FDA clears catheter-based 4D visualization platform for complex heart procedures
LUMA Vision, a medical device company based out of Ireland and Germany, has received U.S. Food and Drug Administration (FDA) clearance for its new catheter-based visualization technology designed to help clinicians during interventional electrophysiology and structural heart procedures.
The Verafeye Visualization Platform allows operators to deliver 2D and 4D ultrasound images in real time. The catheter was built with maneuverability and increased visibility in mind; it can capture images of up to 120 mm from the tip and provide views of the patient’s anatomy from all angles.
According to LUMA Vision, the newly cleared platform has also been designed to handle the magnetic tracking and navigation of third-party catheters.
“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,” Fionn Lahart, CEO of LUMA Vision, said in a statement. “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.”
“The approval of Verafeye is a major advancement in intraprocedural cardiac imaging,” added Anish Amin, MD, system medical chief for cardiac electrophysiology with OhioHealth Heart and Vascular. “Verafeye imaging capabilities demonstrate a necessary path forward in precision imaging and a strong foundation to further advance the standard of care.”
Momentum continues
In January, the company announced that clinicians had performed the first procedures using the Verafeye technology. Gábor Széplaki, MD, PhD, the head of cardiac electrophysiology at Mater Private Hospital in Dublin, Ireland, led the team that performed those procedures.
“This innovative technology represents a major leap forward in our ability to deliver precise and effective treatments for patients with complex heart conditions,” he said at the time. “Verafeye has the ability to provide all the navigation and imaging needed during today's single shot procedures in one system.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.