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.