SBIR Phase I: Technology development and pre-clinical testing of a novel minimally invasive catheter-based blood clot-retrieval and clot-filtering device

该小型企业创新研究（SBIR）第一阶段项目旨在开发行业首个基于导管的中风治疗设备，该设备既可作为血栓提取设备，也可作为血栓过滤设备。中风是纳税人的主要经济负担，每年花费655亿美元。中风患者的平均终身医疗费用为140，048美元。治疗急性中风的第一步是清除血块，恢复大脑的重要血液供应。然而，现有的基于导管的治疗方法在清除血栓方面只取得了一定的成功，并且在不到三分之二的中风患者中有效。此外，这些疗法会将碎片释放到血流中，导致进一步的中风。该项目的研究目标是对更有效的血栓取出装置和血栓过滤装置进行临床前测试，使现有的中风治疗更安全。由于全球中风负担惊人，因此该研究的广泛影响是深远的。美国每年发生780，000例中风，全世界发生近2050万例中风。预计该项目将产生重要成果。首先，将确认该凝块回收装置在清除血栓方面的有效性。其次，将证实该凝块过滤装置在基于导管的卒中治疗期间防止碎片释放的有效性，从而使这些手术更安全。这种公私伙伴关系预计将对社区产生重要的积极影响，挽救生命，创造就业机会，减少纳税人中风的经济负担。

This Small Business Innovation Research (SBIR) Phase I project aims to develop the industry's first catheter-based stroke treatment device that serves both as a blood clot-retrieval as well as a clot-filtering device. Stroke is a major economic burden on the tax payer costing $65.5 billion/year. The mean lifetime healthcare cost for a stroke patient is $140,048. The first step in the treatment of acute stroke is the removal of the blood clot to restore vital blood supply to the brain. However, existing catheter-based therapies have only shown modest success in removing clots and are effective in less than two-thirds of stroke patients. In addition, these therapies can release debris into the blood stream causing further strokes. The research objective of this project is to perform pre-clinical testing of a more effective clot-retrieval device and a clot-filtering device that can make existing stroke therapies safer.The broader impacts of this research are far-reaching as the global stroke burden is staggering. Each year 780,000 strokes occur in the US and nearly 20.5 million strokes occur worldwide. This project is projected to yield important outcomes. First, the efficacy of this clot-retrieval device in removing blood clots will be confirmed. Second, the efficacy of this clot-filtering device will be confirmed in preventing release of debris during catheter-based stroke treatments thereby making these procedures safer. This public-private partnership is expected to have an important positive impact on the community by saving lives, creating jobs, and decreasing the economic burden of stroke on the tax payer.