SBIR Phase I: Development of a textile-based retrievable stent for stroke that can be personalized to a patient's clot burden and retrieve long clots using torsion.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project is significant as it offers a disruptive new mechanical approach to stroke treatment. Each year, 795,000 strokes occur in the U.S., 1.7 million strokes in Europe, and nearly 20.5 million strokes worldwide. This public-private partnership is expected to have an important positive societal impact on the community by saving lives especially the elderly and decreasing the economic burden of stroke on the taxpayer. This life-saving device has a unique value proposition for health-systems with lower inventory costs from a single size device, and for patients with better vessel re-opening rates, thereby saving brain cells. This textile-based braided retrievable stent, also known as an embolus retriever or thrombectomy-assist device is an innovation that will enhance scientific and technological understanding of how personalized medicine can transform the care of stroke patients in the U.S. and worldwide. This SBIR Phase I project proposes to bring to market the industry?s longest blood clot or embolus retriever for removal of short and long clots that can be customized by the operator based on each patient?s clot burden. In addition, it is the first textile-based braided retrievable stent which works well in conjunction with standard catheter-based aspiration systems for stroke treatment developed in the U.S. that can be personalized to all clot lengths. Stroke is a major problem causing 5.5 million deaths worldwide and currently there is no cost-effective and efficacious treatments. The mean lifetime healthcare cost per stroke patient is $140,048. This textile-based clot retrieval device (aka thrombectomy-assist device) is a cost-effective medical device that can help save a stroke patient?s life. The methods and approaches of this project is to compare via pre-clinical tests the ability of a textile-based medical device to re-open vessels blocked with clots compared with existing approved treatments. The goals and scope of the research will focus on the ability to rapidly re-open vessels that are blocked by clots. This paves the way for personalized medicine with a customizable stroke treatment device that can be tailored to a patient?s clot burden. 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.