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December 4, 2024
Centerline Biomedical’s IOPS Guidewire Handle Receives FDA Clearance
December 4, 2024—Centerline Biomedical, Inc. announced that the company received FDA 510(k) clearance for its IOPS intra-operative positioning system guidewire handle.
According to the company, the IOPS guidewire handle is used with the sensorized IOPS guidewire and the new Viewpoint catheter to support three-dimensional (3D) navigation of a patient’s vasculature. When combined with the IOPS software’s algorithms, clinicians can visualize these devices in real time and with minimized dependence on fluoroscopy during procedures. Centerline announced FDA clearance of the Viewpoint catheter in August 2024.
The company noted that IOPS was designed with advancements in both device navigation and visualization to remove the need for prolonged fluoroscopy during endovascular procedures, promoting the safety of clinicians and patients.
The IOPS advancements in visualization include the Spintegration feature, which enables multicolor 3D visualization of the arteries and their branches before, during, and after stent graft placement. In addition, new software features add the capability to create and display 3D wireframe vessel models for procedure mapping, stated Centerline.
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