IOPSxV: Novel Visualization for Non-Fluoroscopic 3D Image Guidance for Peripheral Vascular Interventions.

Project Summary/ Abstract This SBIR Direct to Phase II project will advance the commercialization of our Intra-Operative Positioning System (IOPS) to improve visualization and navigation of atherosclerotic vessels in patients with peripheral vascular disease (PVD), thereby overcoming limitations of 2D x-ray fluoroscopy (“fluoro”) in peripheral interventions. Our novel product employs registration methods that will increase precision of navigation of catheters and guidewires devices through narrow or heavily calcified vasculature and provide visualization from angles and with enhancement not achievable with fluoro. This approach not only enables operators to see better during an intervention, but also dramatically reduces the need for exposure to harmful ionizing radiation that poses health risks for both clinicians and patients. Importantly, enabling this novel level of visualization will lead to a potential paradigm shift in the way PVD is treated. In this study we endeavor to demonstrate new IOPS capabilities to 1) remove the IOPS dependency on cone beam CT imaging while maintaining high tracking accuracy, 2) provide immediately intuitive 3D color visualization of calcified vessels for enhanced surgical experience and outcomes, and 3) reduce the time and radiation dose required for navigation. Ultimately, non-radiation-based visualization that is not limited by a 2D display will impact healthcare by decreasing radiation to patients and OR staff, reducing procedure time and cost, and decreasing operative and postoperative complications. Centerline Biomedical has invested significant company resources to develop the IOPS technology, which is currently under FDA review for 510(k) clearance. The next generation product, IOPSxV, builds on this platform and, has been demonstrated to have feasibility to provide clinicians unparalleled ability to navigate through a blood vessel which may have complex calcified plaque and be distending or deforming. In Phase II, we will optimize miniaturized sensor-equipped catheters and patient position tracking pads, and validate the calcification and deformation registration mathematical models in the human cadaveric limb model. Phase II outcomes will demonstrate that use of IOPSxV as an adjunct to and confirmed by fluoro is safe and effective and can lower radiation dose, while obtaining superior imaging of diseased vasculature in PVD patients, paving the way to realizing the full clinical and economic benefits of endovascular interventions. Converting this innovation to a product will expand the patient population eligible for minimally-invasive PVD treatment. Additionally, by reducing component costs and dependence on complex imaging typically found only in large hybrid surgical suites, we will be making IOPS more affordable and accessible to rural populations. Commercialization of our technology will have implications beyond PVD, to include many emerging vascular, cardiac, and neurologic procedures to benefit a broader population of patients, caregivers, and enable delivery of better quality healthcare globally.!Project Narrative This project provides new non-fluoroscopic, high-precision 3D visualization and navigation of stenotic peripheral vasculature using advanced visualization algorithms, miniaturized sensors integrated into endovascular tools, and novel registration methods during minimally invasive procedures for the treatment of peripheral vascular disease. It is implemented by building upon an existing image guidance technology for treatment in larger vessels, by miniaturizing components while reducing cost, extending visualization capabilities, and eliminating dependence on complex and expensive rotational angiography. This approach overcomes limitations of todayandapos;s fluoroscopy-dependent 2D visualization, makes interventions safer by decreasing the need for ionizing radiation, enhances cliniciansandapos; ability to achieve faster and better surgical outcomes with fewer complications.