US-based medical technology company Centerline Biomedical has received the US Food and Drug Administration (FDA) 510(k) approval for its new IOPS Guidewire Handle.
The IOPS Guidewire Handle is a second-generation device and the most recent addition to the company’s patented IOPS (Intra-Operative Positioning System) technology portfolio.
It is designed for use with the company’s sensorised IOPS Guidewire and new Viewpoint Catheter to support 3D navigation of a patient’s vasculature.
When used together with the algorithms of the IOPS software, clinicians can visualise the device in real time, significantly reducing the dependence on fluoroscopy during procedures.
Centerline founder and CTO Vikash Goel said: “Centerline began with a focus on directly addressing clinicians’ needs and we continue to evolve it based on our experience in the field.
“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.”
According to the company, clinicians depend on fluoroscopy or live x-ray during endovascular procedures, to visualise medical devices inside the body.
Fluoroscopic imaging may expose the clinicians and staff to x-ray radiation, which may pose risks for DNA damage and other medical complications over time.
Centerline said that its IOPS device prevents the need for prolonged fluoroscopy during endovascular procedures to ensure the safety of clinicians and patients.
Building on its advanced features, IOPS enables multicolour 3D visualisation of the arteries and their branches before, during, and after stent graft placement.
The device provides vascular mapping with colourful, 3D images showing the fine features of diseased arteries, which are not visible with traditional 2D grayscale x-ray fluoroscopy.
Furthermore, the new software features that are offered only through IOPS will help create and display 3D wireframe vessel models for procedure mapping, said Centerline.
