Centerline Biomedical has announced that it has received the US Food and Drug Administration (FDA) 510(k) approval for its new Intra-Operative Positioning System (IOPS) guidewire handle.
The IOPS guidewire handle is a second-generation device and the most recent addition to the company’s patented IOPS technology portfolio.
It is designed for use with the company’s sensor IOPS guidewire and new Viewpoint catheter to support three-dimensional (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 chief technology officer 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 hVieweels 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.
Centerline has said that its IOPS device prevents the need for prolonged fluoroscopy during endovascular procedures to ensure the safety of clinicians and patients.
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.
