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Centerline Biomedical's IOPS Guidewire Handle Receives FDA 510(k) Clearance

• Centerline Biomedical's IOPS Guidewire Handle, a second-generation device, has received FDA 510(k) clearance, enhancing its IOPS technology portfolio. • The IOPS Guidewire Handle, used with a sensorized guidewire and viewpoint catheter, supports real-time 3D navigation of vasculature. • The device minimizes reliance on fluoroscopy during endovascular procedures, reducing radiation exposure for clinicians and patients. • New features, like Spintegration, enable multicolor 3D visualization of arteries, improving vascular mapping and anatomical detail during procedures.

Centerline Biomedical Inc. has announced that its IOPS Guidewire Handle has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This marks the latest advancement in the company's Intra-Operative Positioning System (IOPS) technology, designed to enhance cardiovascular navigation and visualization during endovascular procedures.
The IOPS Guidewire Handle is designed for use with the sensorized IOPS Guidewire and the next-generation viewpoint catheter. Together, these tools provide clinicians with real-time 3D navigation of a patient’s vasculature. The system's proprietary algorithms enable clear visualization of devices, reducing the need for fluoroscopy during procedures.

Reducing Fluoroscopy Exposure

During endovascular procedures, clinicians commonly use fluoroscopy (live X-ray) to visualize medical devices inside the body. However, this exposes both clinicians and staff to X-ray radiation, which can accumulate over time and potentially lead to DNA damage and other medical complications. The IOPS Guidewire Handle is designed to minimize the need for prolonged fluoroscopy, thereby promoting safety for both clinicians and patients through advancements in device navigation and visualization.

Enhanced Visualization with Spintegration

The IOPS Guidewire Handle features advancements in visualization, including the novel Spintegration feature. This enables multicolor 3D visualization of arteries and their branches before, during, and after stent graft placement. The result is detailed vascular mapping with colorful, 3D images displaying the fine features of diseased arteries, including calcifications, occlusions, and dissections. These anatomical formations may not be as visible when using traditional 2D grayscale X-ray fluoroscopy. New software features available on IOPS also allow for the creation and display of 3D wireframe vessel models for procedure mapping.

Company Statement

"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."
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Reference News

[1]
Centerline Biomedical receives US FDA 510(k) clearance for its new IOPS Guidewire ...
pharmabiz.com · Dec 6, 2024

Centerline Biomedical Inc. received FDA 510(k) clearance for its IOPS Guidewire Handle, enhancing 3D navigation and redu...

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