Demonstrating commitment to continuous portfolio innovation, Centerline Biomedical receives FDA 510(k) clearance for new IOPS® Guidewire Handle and launches its latest software advancements

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.

“Centerline began with a focus on directly addressing clinicians’ needs and we continue to evolve it based on our experience in the field,” said Vikash Goel, Founder and CTO. “Clearance for the new IOPS Guidewire Handle comes on the heels of the launch of our next-generation Viewpoint catheter and our sixth software release. I couldn’t be more thrilled with our innovative product development team as they continue to advance the IOPS platform.”

To learn more about the IOPS platform visit www.centerlinebiomedical.com/iops-technology.

About Centerline Biomedical

Founded in 2015, Centerline Biomedical, Inc. 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