FDA Clears Centerline Biomedical’s New IOPS Guidewire Handle

Centerline Biomedical Inc. has garnered U.S. Food and Drug Administration (FDA) 510(k) clearance for its new IOPS Guidewire Handle, a second-generation device that helps support 3D navigation of the body’s vasculature.

The most recent addition to the company’s patented IOPS (Intra-Operative Positioning System) technology portfolio, the IOPS Guidewire Handle is designed to be used with the sensorized IOPS Guidewire and and new Viewpoint Catheter. When combined with proprietary IOPS software algorithms, clinicians can 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 clinician and patient safety. This is achieved through advancements in both device navigation and visualization.

IOPS advancements in visualization, including the 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, according to the company.

“Centerline began with a focus on directly addressing clinicians’ needs and we continue to evolve it based on our experience in the field,” Centerline Biomedical Founder/Chief Technology Officer Vikash Goel said. “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 product development team as they continue to advance the IOPS platform.”

Founded in 2015, Cleveland-based Centerline Biomedical Inc.’s commercially available platform, IOPS, enables improved visualization and navigation in endovascular procedures. IOPS is cleared by the FDA for use in the descending aorta.