Real-Time, 360-Degree Imaging Enhances
Precision and Confidence in Cardiac Procedures
DUBLIN, April 16,
2025 /PRNewswire/ -- LUMA Vision Ltd., an innovative
leader in advanced cardiac imaging and navigation, today announced
the FDA clearance of its VERAFEYE™ Visualization Platform. This
novel catheter-based imaging system provides real-time, two and
four-dimensional, 360-degree visualization, 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 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".
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 that need precise visualization to deliver effective
treatment. By providing real-time, volumetric images of the heart
in combination with magnetic navigation, the interactive
visualization of the VERAFEYE system enables clinicians to make
more informed decisions, potentially reducing procedure time and
minimizing risks.
"The approval of VERAFEYE is a major advancement in
intraprocedural cardiac imaging," said Dr. Anish Amin, System
Medical Chief for Cardiac Electrophysiology, OhioHealth Heart and
Vascular. "VERAFEYE's imaging capabilities demonstrate a necessary
path forward in precision imaging and a strong foundation to
further advance the standard of care."
About LUMA Vision
LUMA Vision is a privately held,
medical device company based in Dublin,
Ireland and Munich,
Germany. LUMA Vision designs and develops cutting edge
innovative technologies to significantly advance healthcare and
solve truly global unmet clinical needs. VERAFEYE™ is a novel
ultrasound based cardiac visualization and navigation platform for
generating a 360-degree view, navigating and imaging all structures
and devices around the catheter with an unprecedented field of
view. With a commitment to advancing patient care, LUMA Vision
focuses on delivering groundbreaking products that enhance clinical
outcomes and improve lives around the world. LUMA Vision was
founded by CEO Fionn Lahart and CTO
Christoph Hennersperger. Learn more
about LUMA Vision and VERAFEYE at www.lumavision.com
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