GENTUITY LLC — Department of Health and Human Services SBIR Phase II: 103

Description

PROJECT SUMMARY This program will commercialize a high speedhigh resolutionneuroendovascular imaging platform that allows neurointerventionalists to directly visualize intravascular devices and their interaction with vessels during treatment of brain aneurysmsThe miniaturization of the design features of neurovascular stents and flow diverters has enabled an explosion of technologies available for endovascular treatment of strokeHoweverimaging technology has not kept pace with device technology to enable endovascular surgeons sufficient resolution to adequately visualize the device vessel relationshipAs suchthere is a critical need for high resolution imaging specific to cerebrovascular disease and endovascular treatmentsOptical coherence tomographyOCTis a relatively new imaging technique approved by FDA for intracoronary imaging that delivers the highest axial resolutionmamong all the other available modalitiesHowevercommercially available OCT solutions are not compatible with microcatheters used for neuro endovascular intervention and are unsuitable for highly tortuous neurovascular anatomyDuring SBIR Phase IGentuity demonstrated a reduced sizehigh resolutionhigh frequency OCT imaging probe designed for cerebrovascular imagingthe Vis N deviceThe Vis N is compatible with neurovascular microcatheter delivery tools and workflow and can navigate tortuous vasculature using novel optics and scanning mechanismsWe successfully demonstrated the feasibility of the proposed technology in a combination of in vitro vascular phantoms and in vivo pre clinical modelsincluding cutting edge neuroendovascular implantsThe aim of the submitted project is to further develop the proposed imaging device for clinical use and to demonstrate its safety and efficacy in a pre clinical modelUpon completion of this Phaseapplicationwe will be poised to study this neurovascular imaging catheter in an IDE to obtain regulatory approval and enter the commercialization phase!NARRATIVE The goal of this program is to provide a highly effectivehigh resolutionimaging tool for the guidance of endovascular procedures for brain aneurysm repairX ray angiographycomputed tomographyCTand magnetic resonance imagingMRIare the primary imaging modalities used in the clinic to provide perioperative guidance for aneurysm repair procedureshoweverthey lack sufficient resolution to adequately assess device vessel interactionIn this applicationwe propose to advance to commercialization a reduced sizehigh speedhigh resolutionoptical imaging probe optimized for cerebrovascular imaging such that it is compatible with neurovascular microcatheter delivery tools and is capable of imaging while navigating the tortuous vascular anatomy