Centerline Biomedical has secured the US Food and Drug Administration (FDA) expanded 510(k) clearance for its Intra-Operative Positioning System (IOPS).
In 2019, IOPS was initially approved in the US, and current FDA approval extends the system’s applications, for use in minimally invasive surgeries.
The IOPS platform is designed to reduce dependence on fluoroscopy and enhance safety by reducing X-ray radiation exposure for clinicians and patients.
It uses existing patient anatomical images to create detailed, multi-colour 3D vascular maps of the anatomy, including arteries and veins.
The maps provide a complete view of the anatomy, highlighting features such as calcifications and occlusions that are not easily visible with traditional 2D X-ray fluoroscopy.
They guide IOPS guidewires and catheters with real-time navigation of the vasculature during procedures, reducing the need for prolonged fluoroscopy during procedures.
Centerline Biomedical CEO Gulam Khan said: “With this clearance, our ground-breaking, image guidance technology, IOPS can be utilised across a larger market opportunity in new and expanded clinical applications.
“We are thrilled to be able to introduce more clinicians to IOPS. In tandem, Centerline continues to aspire to improve image guidance, reduce radiation exposure inherent with x-ray-based imaging, and offer a safer procedure environment for patients and clinicians.”
IOPS is designed to evaluate vascular anatomy, support real-time tip positioning and navigate using sensor-equipped catheters and guidewires.
It is intended for use as an adjunct to fluoroscopy in endovascular interventions, particularly in the peripheral, aortic, and aortic side branch vasculature.
The IOPS platform includes a mobile cart supported by unique visualisation software and intelligent, sensorised catheters and guidewires.
The Cleveland Clinic Cerebrovascular Centre neurosurgeon and professor of neurosurgery Peter Rasmussen said: “The expanded indication promises to open IOPS to neuro endovascular physicians and the neurovasculature.
“This may be useful to help solve neurovascular access problems during all cerebrovascular interventions, particularly during acute stroke intervention via greater visualisation of the anatomy.”
