CLEVELAND, Aug. 6, 2024
/PRNewswire/ -- Centerline Biomedical, Inc. ("Centerline"), an
innovation leader in cardiovascular navigation and visualization
systems, announced today that the IOPS Viewpoint Catheter has
received US Food and Drug Administration (FDA) 510(k) clearance.
The Viewpoint Catheter is the most recent addition to the company's
patented IOPS (Intra-Operative Positioning System) portfolio.
Centerline Biomedical receives FDA 510(k)
clearance for new IOPS® Viewpoint Catheter
Viewpoint Catheter, a low profile 6 French (Fr) catheter
available in multiple tip shapes and lengths, is designed for
precision access to provide three-dimensional (3D) navigation
feedback to clinicians. When Viewpoint Catheters are used in
combination with the proprietary algorithms of the IOPS software,
clinicians can clearly visualize endovascular tools in real-time
and reduce their dependency on fluoroscopy systems. The result is
state of the art image-guided, real-time navigation designed to
revolutionize the way endovascular procedures are performed. This
is achieved while reducing exposure to harmful radiation emitted
from the x-ray fluoroscopy systems that are typically used to see
vessels during these procedures.
At its core, the IOPS platform is designed to enhance
visualization, minimize procedure times, and reduce total radiation
exposure for the benefit of both patients and health care
providers.
"Development of our second-generation portfolio for IOPS has
been the top priority for Centerline Biomedical. Viewpoint
Catheters were developed with input from leading clinicians to best
meet their procedure needs," said Gulam
Khan, CEO of Centerline Biomedical. "Our company continues
to reenvision the field of endovascular interventions developing
technologies designed with the express purpose of improving
outcomes for both providers and patients."
About Centerline Biomedical
Founded in 2015, Centerline Biomedical is headquartered in
Cleveland, Ohio. The company's
commercially available platform, IOPS®, enables improved
visualization and navigation in endovascular procedures. IOPS has
510(k) clearance from the US FDA for use in the descending aorta.
The company continues investment in development to enhance the
current technology platform and expand image guidance in
transcatheter procedure applications.
Visit www.centerlinebiomedical.com for more
information.
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SOURCE Centerline Biomedical