Centerline Biomedical receives FDA 510(k) clearance for new IOPS® Guidewire Handle

CLEVELAND, Dec. 4, 2024 /PRNewswire/ -- Centerline Biomedical, Inc. ("Centerline"), an innovative leader in cardiovascular navigation and visualization systems, announced that the company has received US Food and Drug Administration (FDA) 510(k) clearance for its new IOPS Guidewire Handle

 This second-generation device is the most recent addition to the company’s novel, patented IOPS (Intra-Operative Positioning System) technology portfolio. The IOPS Guidewire Handle is used with the sensorized IOPS Guidewire and new Viewpoint™ Catheter to support 3D navigation of a patient’s vasculature. When combined with the proprietary algorithms of the IOPS software, clinicians are able to clearly visualize these devices in real-time and with minimized dependence on fluoroscopy during procedures.

During endovascular procedures, clinicians typically rely on fluoroscopy, or live x-ray, to see medical devices inside the body. Using fluoroscopic imaging exposes the treating clinicians and staff to x-ray radiation, which aggregated over time may introduce risks for DNA damage and other medical complications. IOPS was designed without the need for prolonged fluoroscopy during endovascular procedures to promote the safety of clinicians and patients. This is achieved through advancements in both device navigation and visualization. 

IOPS advancements in visualization, including the novel Spintegration™ feature, enables multicolor 3D visualization of the arteries and their branches before, during, and after stent graft placement. The result is unparalleled vascular mapping with colorful, 3D images displaying the fine features of diseased arteries; including calcifications, occlusions, dissections, and other anatomical formations not as visible when using traditional 2D grayscale x-ray fluoroscopy. In addition, new software features, only available on IOPS by Centerline, add the capability to create and display 3D wireframe vessel models for procedure mapping.

Sign up for Blog Updates