STTR Phase I: Endovascular Thrombectomy System for Ischemic Stroke

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The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to improve survival and functional outcomes for stroke patients. Stroke remains a leading cause of death among Americans and is the largest source of long-term disability in the U.S. and around the world. Every 30 seconds, an American suffers a major stroke, most commonly caused by a clot obstructing a large cerebral artery supplying a critical area of the brain. This project’s clot-removal technology aims to enable rapid and efficient removal of clot from the cerebral vessels using minimally-invasive image-guided techniques, thereby improving the chances of full recovery and an independently functional outcome. The broader benefit for society is to reduce death or permanent disability from ischemic stroke with its resultant family, community, and economic burden. This Small Business Technology Transfer Phase I project will lead to the development of a medical device to enable efficient removal of blood clots from the brain arteries of a stroke victim. The platform technology is constructed from microscopic tubes of superelastic metal alloy integrated with a proprietary pattern of laser-cut apertures. The device can be delivered to the stroke clot through a microcatheter to create a shape-formed array of clot-capture elements within a patient’s artery. Tandem capture devices optimize the clot capture system and can be positioned on either edge of a clotted segment within a brain artery. Optimal shape, thickness and materials of the clot capture elements and the delivery system will be characterized, developed, and verified. The proposed work will utilize a previously validated model of stroke thrombectomy to characterize and quantify fundamental clot capture parameters (clot stabilization, retention, and retrieval) among multiple discrete capture node embodiments. Radial force, coefficient of drag during withdrawal inside a cerebral blood vessel and device trackability will be measured for each design using robust three-dimensional human anatomic models of cerebral vessels. The project will enable a design freeze of the optimal device design and validate its performance using a preclinical animal model.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.