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510(k) clearance by FDA further addresses the market need to reduce physician exposure to harmful x-ray radiation during image-guided, endovascular procedures.
Centerline Biomedical, Inc. a Cleveland Clinic Innovations portfolio company and pioneer in cardiovascular navigation and visualization systems, recently announced that its IOPS® (Intra-Operative Positioning System) Viewpoint Catheter has obtained 510(k) clearance from the US Food and Drug Administration (FDA). This catheter, part of the IOPS portfolio, is a low-profile 6 French (Fr) catheter available in various tip shapes and lengths. It is engineered to provide precise access for three-dimensional (3D) navigation feedback to clinicians, reducing their reliance on fluoroscopy systems and offering real-time visualization of endovascular tools.
By leveraging the IOPS software's proprietary algorithms, the Viewpoint Catheter aims to revolutionize endovascular procedures by enhancing visualization, minimizing procedure times, and reducing radiation exposure for both patients and healthcare providers. Gulam Khan, CEO of Centerline Biomedical, highlighted the company's dedication to reimagining endovascular interventions and prioritizing the development of the second-generation IOPS portfolio. The Viewpoint Catheters were developed in collaboration with leading clinicians to address their procedural needs and improve outcomes for providers and patients alike.
Read the full press release via PR Newswire.
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