Centerline Biomedical receives FDA 510(k) clearance for new IOPS® Viewpoint Catheter, further addressing market need to reduce physician exposure to harmful x-ray radiation during image-guided, endovascular procedures

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Aug 06, 2024, 17:12 ET

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.

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.

SOURCE Centerline Biomedical