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

Description

PROJECT SUMMARY The goal of this program is the development of a high resolution neuroendovascular imaging platform that provides detailed information on intravascular devices used to treat brain aneurysms Miniaturization of the design features of neurovascular stents and flow diverters FD with braided wires of m and laser cut features of m has enabled an explosion of technology available for endovascular treatment of stroke Despite these advances however several questions remain unanswered including the mechanisms of aneurysm rupture after FD treatment the fate of jailed perforating vessels and long term patency rates Non invasive imaging technology has not kept pace with device technology to enable endovascular surgeons sufficient resolution to adequately assess the device vessel relationship As such there is a critical need for high resolution imaging specific to cerebrovascular disease and endovascular treatments Intra vascular optical coherence tomography OCT is a relatively new imaging technique approved by FDA for the coronary vasculature imaging that delivers the highest axial resolution m among all other available modalities However commercially available OCT catheter sizes F mm are not compatible with microcatheters used for neuro endovascular intervention do not allow for navigation in the highly tortuous neurovascular anatomy In this application we seek to develop a reduced size high resolution imaging catheter compatible with neurovascular microcatheter delivery tools and workflow capable of navigating tortuous vasculature using novel optics and scanning mechanisms We aim to demonstrate feasibility in a combination of in vitro vascular phantoms of cerebrovascular pathology and in vivo animals model including cutting edge neuroendovascular implants Upon completion of this Phase application we will have sufficient preliminary data showing the superiority of intravascular OCT imaging as compared to gold standard x ray angiography and cone beam CT to enter into a commercialization phase that will seek regulatory approval for the technology NARRATIVE Recent advances in endovascular treatments for brain aneurysms include new technology such as endoluminal flow diverters endosaccular flow disrupters and bifurcation stents for assisted coil embolization However imaging technology does not have sufficient resolution for proper positioning of the devices with respect to the lesion and prevention of device malapposition that may lead to thromboembolic complications Several questions remain unanswered including the mechanisms of aneurysm rupture after endovascular treatment prevention of distal thromboembolic events during intervention the fate of jailed perforating vessels and long term patency rates Current imaging technologies lack sufficient resolution to adequately assess neurovascular device vessel relationship and arteries microstructure and to date no neurovascular imaging modality is available to precisely identify device characteristics In this application we seek to develop a reduced size high resolution imaging probe compatible with neurovascular microcatheter delivery tools capable of navigating tortuous vasculature using novel optics and scanning mechanisms and demonstrate it in vivo