Centerline Biomedical, Inc. (“Centerline”), an innovative leader in cardiovascular navigation and visualization systems, announced that the company has received US Food and Drug Administration (FDA) 510(k) clearance of expanded indications for its Intra-Operative Positioning System (IOPS). This news is complemented by the recent 510(k) clearance of the IOPS Fiducial Tracking Pad, a second-generation lower profile device useful in broader applications of the IOPS platform.
“With this clearance, our ground-breaking, image guidance technology, IOPS can be utilized across a larger market opportunity in new and expanded clinical applications,” said Gulam Khan, CEO of Centerline Biomedical. “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.”
Dr. Peter Rasmussen, Neurosurgeon in the Cerebrovascular Center and Professor of Neurosurgery at The Cleveland Clinic says, “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 visualization of the anatomy.”
During minimally invasive surgeries, clinicians typically rely on fluoroscopy, or live x-ray, to see anatomy and medical devices inside the body. Use of fluoroscopic imaging exposes treating clinicians and patients to x-ray radiation, which aggregated over time, introduces risks for DNA damage and other medical complications. IOPS was designed to minimize the need for prolonged fluoroscopy use and promote the safety of both clinicians and patients. This is achieved through advancements in both device navigation and visualization.
The IOPS platform makes use of patient anatomical images or scans already captured for diagnosis and procedure planning to create multi-color, 3D vascular maps. These interactive maps of the anatomy, including arteries and veins, can be displayed in multiple views and highlight the finer features of diseased vessels; including calcifications, occlusions, dissections, and other anatomical and soft tissue formations not clearly visible when using traditional 2D grayscale x-ray fluoroscopy. During procedures, the maps guide IOPS proprietary, sensorized guidewires and catheters during real-time navigation of the vasculature – while minimizing dependence on fluoroscopy.
The IOPS (Intra-Operative Positioning System) is intended for the evaluation of vascular anatomy as captured using 3D modeling from previously acquired scan data. It is intended for real-time tip positioning and navigation using sensor-equipped, compatible catheters and guidewires used in endovascular interventions in the peripheral, aortic and aortic side branch vasculature. The system is indicated for use as an adjunct to fluoroscopy. The IOPS does not make a diagnosis.
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