3-D Navigation of the Aortic Anatomy Without Fluoroscopy (Slideshow)

A novel endovascular navigation technology developed by Cleveland Clinic researchers has successfully completed a second round of preclinical testing on its way toward hoped-for market entry in the second half of 2017. We previewed the technology — known as the Intraoperative Positioning System (IOPS) — earlier this year, but the time seems right for a closer look in the slideshow below. Details on on the latest IOPS testing follow at the bottom of this post.

<p><strong>Cannulation of the right renal artery.</strong> IOPS provides full-color, three-dimensional (3-D) visualization of the aortic anatomy. Its intuitive customizable interface allows the clinician to appreciate the true geometry of the vasculature with simultaneous views from multiple angles. This visualization is generated using a low-level electromagnetic tracking field rather than the ionizing radiation of fluoroscopy.</p>

<p><strong>3-D visualization of catheter and guide wire inside the aorta.</strong> As a visual aid, IOPS marks the ostium of each branch vessel to aid in navigation. Guide wires and catheters are also rendered in 3-D inside the anatomy, displaying each instrument’s position and orientation as well as the shape of its tip.</p>

<p><strong>A “down the barrel” view.</strong> IOPS is capable of providing imaging that cannot be approximated with fluoroscopy. When accessing visceral vessels during endovascular aortic repair, assessment of the relative clock position between the catheter and the branch vessels is critical but also challenging with fluoroscopy. IOPS provides optimal visualization for this task.</p>

<p><strong>Mobility on demand.</strong> The IOPS technology is housed in a mobile cart that can be moved into an operating suite as needed. The tracking hardware attaches to the OR table in a matter of minutes. IOPS makes use of existing multidetector CT and cone beam CT imaging and is fully compatible with fluoroscopy, ensuring a minimal effect on surgical workflow.</p>

<p><strong>IOPS in preclinical use.</strong> Three preclinical studies have been performed to demonstrate IOPS’ navigational capabilities. In a porcine model, clinicians were able to cannulate the left renal artery, right renal artery, superior mesenteric artery and celiac trunk without using fluoroscopy to navigate.</p>

<p><strong>Comparison of IOPS to fluoroscopy.</strong> In preclinical testing, the left renal artery was accessed using IOPS (left) for navigation. To verify correct cannulation, the vessel was imaged using fluoroscopy and contrast dye (right).</p>

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IOPS extracts the centerlines of the aorta and branch vessels from a patient’s CT images to mathematically construct a high-quality 3-D model of the relevant vasculature. Electromagnetic tracking enables use of the model in a GPS-like manner to guide navigation during minimally invasive endovascular repairs of the aorta, reducing reliance on radiation-inducing fluoroscopy.

The latest round of IOPS testing involved two more preclinical studies, in July and August, on the heels of the first study in May 2016.

“This second round of work verified our ability to navigate the aorta and its branches, selecting the celiac artery, superior mesenteric artery and renal arteries, with the use of fluoroscopy limited to verification of catheter location,” says Cleveland Clinic vascular surgeon Matthew Eagleton, MD, who served as primary investigator.

“This technology will limit the need for extensive fluoroscopy units and provide more detailed anatomy that can be imaged while navigating through it,” adds Dr. Eagleton. “It has the potential to revolutionize vascular surgery.”

Dr. Eagleton has a financial interest in the company developing IOPS, Centerline Biomedical, as chair of its scientific advisory board. Centerline, a Cleveland Clinic Innovations spinoff company, plans to submit IOPS for regulatory approval by the FDA, with a target U.S. market entry in the third quarter of 2017.