Centerline Biomedical receives US FDA 510(k) clearance for new IOPS Viewpoint catheter

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IOPS cart

Centerline Biomedical recently announced that its Intra-Operative Positioning System (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 portfolio.

A press release details that Viewpoint—a low-profile 6-French 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, Centerline Biomedical explains, clinicians can clearly visualise endovascular tools in real-time and reduce their dependency on fluoroscopy systems. The result, according to the company, is state-of-the-art image-guided, real-time navigation designed to revolutionise 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.

The press release continues that, at its core, the IOPS platform is designed to enhance visualisation, minimise procedure times, and reduce total radiation exposure for the benefit of both patients and healthcare 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, chief executive officer of Centerline Biomedical. “Our company continues to re-envision the field of endovascular interventions developing technologies designed with the express purpose of improving outcomes for both providers and patients.”


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