SBIR-STTR Award

The purpose of this Phase I SBIR is to develop an anti-embolic carotid stent based on NeuroSigma’s Thin Film Nitinol Micromesh (TFN Micromesh) technology. Carotid artery stenosis is a major public health problem, and a leading cause of stroke with approximately 10% of the population over 70 suffering from moderate to severe carotid artery stenosis. Open surgical treatment, known as carotid endarterectomy (CEA), is the current gold standard for reducing the incidence of stroke in these patients, but large clinical trials of carotid artery stenting (CAS) have demonstrated encouraging outcomes for the less-invasive CAS approach. Importantly, the Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) demonstrated equivalent long-term outcomes between the two procedures, but found that subjects in the CAS group had a higher rate of stroke during the first 30 days. Subsequent investigations of this phenomena have concluded that prolapse and embolization of atherosclerotic plaque through the stent struts is the likely cause of increased periprocedural strokes. Based 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 embolize. Early clinical reports suggest that this is a successful strategy, but these first-generation devices are limited by both the materials used and the size of micro-pores that is achievable. NeuroSigma’s Dual Endoluminal Layered TFN Advanced (DELTA) stent is fundamentally different from these first-generation devices. The DELTA stent leverages TFN Micromesh technology to create a low-profile stent with pores that are less than 150 micrometers in their largest dimension. In addition, extensive animal testing of other endovascular devices incorporating NeuroSigma’s TFN Micromesh has demonstrated that the Micromesh facilitates rapid tissue in-growth and device endothelialization; a property that could further limit plaque embolization and parent artery stenosis. In this Phase I SBIR we will fabricate prototype DELTA stents and perform a pilot large animal study. In Phase II we will perform formal preclinical benchtop and GLP animal trials that are necessary for an investigational device exemption (IDE) from FDA. If successful, the 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.

Public Health Relevance Statement:
Project Narrative Carotid artery stenosis is a major public health problem and a leading cause of stroke. The current standard of care for most patients with carotid stenosis is an invasive surgical procedure. The purpose of this project is to develop a new type of carotid stent that could facilitate a minimally invasive approach to treating carotid stenosis. If successful, this project could improve the standard of care for the millions of patients worldwide that suffer from carotid stenosis.

Project Terms:
Address; Adoption; Affect; Aneurysm; Animal Testing; Animals; Arterial Fatty Streak; Arteries; artery stenosis; base; biomaterial compatibility; Carotid Endarterectomy; Carotid Stenosis; Carotid stent; Cells; Chronic; Clinical; Clinical Trials; cohort; Data; design; Development; Devices; Dimensions; Embolism; Endarterectomy; External carotid artery structure; Family suidae; Feedback; Film; follow-up; General Population; Generations; Goals; Gold; Growth; high risk; Human; Hyperplasia; Implant; improved; in vivo; Incidence; Inflammatory Response; innovation; Intracranial Aneurysm; Investigation; Jail; Life; minimally invasive; Nature; nitinol; Operative Surgical Procedures; Outcome; Parents; particle; Patients; Pattern; Phase; Polymers; Population; pre-clinical; Preparation; prevent; primary endpoint; Procedures; programs; Property; prototype; Ptosis; Public Health; randomized trial; Reporting; Research; Research Personnel; restenosis; Risk; Safety; scale up; Small Business Innovation Research Grant; standard of care; Stents; Stroke; stroke incidence; Technology; Testing; Therapeutic Embolization; Thinness; Tissues; Titan;