Clinical evaluation and development of a diagnostic multi-modal intravascular imaging system



 DESCRIPTION (provided by applicant): Understanding that not a single imaging technique can alone address needs of all vascular diagnosis, OCT medical imaging Inc. (OCTMI) propose to develop a clinical multimodal intravascular imaging system encompassing ultra-high resolution optical coherence tomography(OCT) and IVUS. This Combined multimodal vascular imaging system will permit cross-sectional visualization of vascular artery with unprecedented resolution and depth not possible with any of these technologies alone. This multi-modal imaging strategy in a single system permits use of a single disposable guide wire, thereby reducing cost to hospital, patients and improving prognosis by early detection. We believe these technologies together will provide 1) critical 3D and cross-sectional details & functional information necessary for identifying vulnerable plaques 2) inside-out view of vessel necessary for stent sizing 3) extent of mal-apposition of stent struts in artery 4) extent of post-stent thrombosis. In a multi-institutional effort, we plan to create this multi-modal probe and necessary hardware in Phase I, followed by extensive clinical trials in phase II before seeking FDA approval and marketing in Phase III