NeuroSigma, Inc. — Department of Health and Human Services SBIR Phase I: NHLBI

Description

Project Summary Abstract The purpose of this Phase I SBIR is to develop an anti embolic carotid stent based on NeuroSigma s Thin Film Nitinol MicromeshTFN MicromeshtechnologyCarotid artery stenosis is a major public health problemand a leading cause of stroke with approximatelyof the population oversuffering from moderate to severe carotid artery stenosisOpen surgical treatmentknown as carotid endarterectomyCEAis the current gold standard for reducing the incidence of stroke in these patientsbut large clinical trials of carotid artery stentingCAShave demonstrated encouraging outcomes for the less invasive CAS approachImportantlythe Carotid Revascularization Endarterectomy Versus Stenting TrialCRESTdemonstrated equivalent long term outcomes between the two proceduresbut found that subjects in the CAS group had a higher rate of stroke during the firstdaysSubsequent investigations of this phenomena have concluded that prolapse and embolization of atherosclerotic plaque through the stent struts is the likely cause of increased periprocedural strokesBased on these observations other groups have developed micro porous carotid stents with the goal of decreasing the size and quantity of atherosclerotic particles that can dislodge from the vessel wall and embolizeEarly clinical reports suggest that this is a successful strategybut these first generation devices are limited by both the materials used and the size of micro pores that is achievableNeuroSigma s Dual Endoluminal Layered TFN AdvancedDELTAstent is fundamentally different from these first generation devicesThe DELTA stent leverages TFN Micromesh technology to create a low profile stent with pores that are less thanmicrometers in their largest dimensionIn additionextensive animal testing of other endovascular devices incorporating NeuroSigma s TFN Micromesh has demonstrated that the Micromesh facilitates rapid tissue in growth and device endothelializationa property that could further limit plaque embolization and parent artery stenosisIn this Phase I SBIR we will fabricate prototype DELTA stents and perform a pilot large animal studyIn Phase II we will perform formal preclinical benchtop and GLP animal trials that are necessary for an investigational device exemptionIDEfrom FDAIf successfulthe DELTA stent could represent a major public health advancement by combining the outcomes of CEA with the convenience and lower risks of a minimally invasive stent procedure Project Narrative Carotid artery stenosis is a major public health problem and a leading cause of strokeThe current standard of care for most patients with carotid stenosis is an invasive surgical procedureThe purpose of this project is to develop a new type of carotid stent that could facilitate a minimally invasive approach to treating carotid stenosisIf successfulthis project could improve the standard of care for the millions of patients worldwide that suffer from carotid stenosis