Luma Vision has announced the US Food and Drug Administration (FDA) clearance of its Verafeye visualisation platform.
As per a company press release, this novel, catheter-based imaging system provides real-time, 2D/4D, 360-degree visualisation, “significantly enhancing” clinician precision and confidence during complex electrophysiology and structural heart procedures. The system is prepared for magnetic tracking and navigation of third-party catheters—which, in the future, will further empower clinicians to perform complex procedures with greater precision and control, the release adds.
“The approval of Verafeye is a major advancement in intraprocedural cardiac imaging,” said Anish Amin (OhioHealth Heart and Vascular, Columbus, USA). “Verafeye’s imaging capabilities demonstrate a necessary path forward in precision imaging and a strong foundation to further advance the standard of care.”
Luma claims that its Verafeye system combines state-of-the-art imaging technology with advanced digital manoeuvrability, enabling clinicians to capture highly detailed, 4D images that update in real time. With imaging depths up to 120mm away from the catheter, it allows for dynamic high-resolution navigation and visualisation of the heart. This contrasts with traditional imaging catheters that provide only 2D imaging, often limiting clinicians’ ability to view the cardiac anatomy from all angles during procedures, the release also notes.
“Our clinical experience with Verafeye is exciting, with the potential to simplify procedural workflow and efficiency,” said Shephal Doshi (Pacific Heart Institute/Cedars Sinai, Los Angeles, USA), investigator of the Verafeye system. “Real-time visualisation and rapid creation of cardiac anatomy can facilitate de novo procedures with greater simplicity.”
“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,” added Luma chief executive officer (CEO) Fionn Lahart. “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.”
Luma’s recent release goes on to state that the successful approval of the Verafeye system and catheter represents a “significant step” toward improving procedural workflows and broadening the potential for many of the innovative technologies requiring precise visualisation to deliver effective treatment.
