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

急性缺血性中风(AIS)是由神经血管中的血块引起的。目前，AIS仍位居第五 在美国是主要的死亡原因，也是导致神经性残疾的主要原因。AIS将 2018年影响了70多万美国人，尽管中风护理最近取得了进展，但仍然存在 死亡或严重残疾的概率为65%。预计到2030年，美国AIS的经济负担将 超过1800亿美元。AIS治疗的标准护理包括在中风发病4.5小时内进行溶栓治疗 对大血管闭塞应尽早行取栓术。然而，尽管血栓切除术被证明是 然而，早期血栓摘除的地理位置较差，仍导致护理上的巨大差异。 在美国，血栓摘除术主要在综合卒中中心(CSC)进行，为此 只有不到170个。CSC认证与广泛的要求相关，包括获得高- 专业水平，全天候护理，专用神经重症监护床位，现场血栓切除术， CT/MR/CTA/MRA成像和参与临床研究。因为相当大的成本是相关的 随着CSC的建立和维护，这些中心集中在人口稠密的城市中心附近， 这可以提供更大的病人数量。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，对于许多人来说，传输延迟可能超过2小时。 为了帮助解决在向所有美国人提供平等的血栓切除机会方面的这一巨大差距，联合 委员会(与AHA/ASA合作)宣布了具有血栓切除能力的卒中中心(TSC) 2018年1月1日的认证计划，目标是创建一种地理上分散的血栓切除术- 有能力的医院网络。然而，考虑到1)相关联的 全天候TSC项目的人员配置成本将很高，2)可供选择的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将集中在高容量的CSC中。 Un&Up发明了一种新型的远程机器人技术，可以支撑关节 委员会的TSC倡议。这项技术的创新涉及到使用与Angiosuite兼容的 基于磁铁的工作站，用于导航神经血管工具，由独特的磁性合金组成，可以 被塑造成可远程导航的小型导丝和微导管。其结果是一种基于磁铁的机器人 平台比以前可能的小40倍，并首次提供机器人解决方案 神经干预主义者。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)建立磁力工作站的原型，2)建立新型的磁力导丝 和微导管，以及3)基于CTA/MRA评估血管模体的装置性能 神经血管数据集。鉴于FDA 510k的强有力预测，预计该技术将按照 510K框架。FDA将在第二阶段提案之前举行提交前会议。

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.