ICorps Administrative Supplement for A Remotely-Operated Robotic Endovascular Platform to Improve Thrombectomy Access

急性缺血性卒中（AIS）是由神经血管中的血块引起的。目前，AIS仍然是第五个 在美国（US）是死亡的主要原因，也是神经残疾的主要原因。人工智能将 2018年影响了70多万美国人，尽管最近中风护理取得了进展， 死亡或严重残疾的几率为65%到2030年，预计美国的AIS经济负担将 超过1800亿美元。AIS标准治疗包括在卒中发作后4.5小时内进行溶栓治疗 以及尽早对大血管闭塞进行血栓切除术。然而，尽管血栓切除术被证明 尽管如此，早期血栓切除术的地理可及性差仍然导致护理的巨大差异。 在美国，血栓切除术主要在综合卒中中心（CSC）进行， 不到170个。CSC认证与广泛的要求相关，包括获得高质量的 专业水平，24/7全天候护理，专用神经重症监护床，现场血栓切除术， CT/MR/CTA/MRA成像，并参与临床研究。因为相当大的成本与 随着CSC的建立和维护，这些中心集中在人口密集的城市中心附近， 这可以提供更大的患者体积。然而，其后果是，超过一半的美国人面临 传输时间超过1小时，并且对于许多传输延迟可以超过2小时。 为了帮助解决在为所有美国人提供平等的血栓切除术方面的这一巨大差距，联合国 委员会（与AHA/阿萨合作）宣布血栓切除术卒中中心（TSC） 认证计划于2018年1月1日开始，目标是创建地理分散的血栓切除术- 强大的医院网络。然而，建立这一海训方案网络将是一个挑战，因为1）相关的 24/7 TSC项目的人员配备成本将很高，2）美国神经放射科医生不到3500人 3）最高水平的专业知识可能仍然集中在高容量的CSC中。 UN&UP发明了一种新颖的远程机器人技术， 委员会的海训方案倡议。该技术的创新涉及到使用一种与血管造影剂兼容的 基于磁体的工作站，用于导航由独特磁性合金组成的神经血管工具， 成形为小的、可远程导航的导丝和微导管。结果是一个基于磁铁的机器人 该平台比以前可能的小40倍，并首次提供机器人解决方案， 神经介入医生UN&UP的团队由领先的磁学、机器人、远程医疗和中风专家组成。 该项目的目标包括：1）建立原型磁铁工作站，2）建立新的磁导丝 和微导管，以及3）基于CTA/MRA评估血管体模中的器械性能 神经血管数据集。鉴于FDA 510 k等同产品的强大性，预计该技术将根据 510 k框架。将在II期提案之前召开FDA预提交会议。

Acute ischemic stroke (AIS) results from a blood clot in the neurovasculature. Currently, AIS remains the 5th leading cause of death in the United States (US) and is the leading cause of neurological disability. AIS will impact more than 700,000 Americans in 2018 and, despite the recent advances in stroke care, there still exists a 65% chance of death or severe disability. By 2030, it is expected that the US’s AIS economic burden will exceed $180B. Standard of care AIS therapies include the use of thrombolysis within 4.5 hours of stroke onset and thrombectomy for large vessel occlusions as early as possible. However, despite thrombectomy’s proven value, poor geographic access to early thrombectomy still results in a large disparity in care. In the US, thrombectomies are largely performed at Comprehensive Stroke Centers (CSCs), for which there are less than 170. CSC certification is associated with extensive requirements, including access to high- level expertise, 24/7 access to care, dedicated neuro intensive care beds, on-site thrombectomy, CT/MR/CTA/MRA imaging, and participation in clinical research. Because considerable costs are associated with setting up and maintaining a CSC, these centers are concentrated near highly-populated urban centers, which can provide larger patient volumes. However, the consequence is that more than half of Americans face transfer times longer than 1hr, and for many, transfer delays can exceed 2hrs. To help address this considerable gap in providing equal thrombectomy access to all Americans, the Joint Commission (in collaboration with the AHA/ASA) announced the Thrombectomy-Capable Stroke Center (TSC) certification program on January 1, 2018, with the goal of creating a geographically-dispersed thrombectomy- capable hospital network. However, building this TSC network will be a challenge given that 1) the associated costs in staffing a 24/7 TSC program will be high, 2) there are less than 3500 US neuroradiologists to draw from, and 3) the highest-level of expertise will likely remain concentrated within in high-volume CSCs. UN&UP has invented a novel and remotely-enabled robotic technology that bolsters the Joint Commission’s TSC initiative. The technology’s innovation relates to the use of an angiosuite-compatible magnet-based workstation to navigate neurovascular tools composed of a unique magnetic alloy, which can be shaped into small, remotely-navigable guidewires and microcatheters. The result is a magnet-based robotic platform than is 40X smaller than previously possible and, for the first time, offers robotic solutions to the neurointerventionalist. UN&UP’s team consists of leading magnetics, robotics, telemedical, and stroke experts. The project’s aims include 1) building the prototype magnet workstation, 2) building novel magnetic guidewires and microcatheters, and 3) assessing device performance in vascular phantoms based upon CTA/MRA neurovascular datasets. Given strong FDA 510k predicates, the technology is expected to be regulated per the 510k framework. An FDA pre-submission meeting will be conducted in advance of a Phase II proposal.