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

ICorps 针对远程操作机器人血管内平台的行政补充，以改善血栓切除术的可及性

• 批准号: 10045638
• 负责人: Francis Milton Creighton
• 金额: $ 5.5万
• 依托单位: UNANDUP, LLC
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-24 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10045638
• 关键词: Acute; Address; Administrative Supplement; Alloys; American; American Heart Association; Anterior; Beds; Blood Circulation; Blood Vessels; Blood coagulation; Caring; Cause of Death; Certification; Cessation of life; Clinical Research; Cobalt; Collaborations; Complex; Custom; Data; Data Set; Devices; Economic Burden; Equipment; Face; Fluoroscopy; Geography; Goals; Health Services Accessibility; Hospitals; Hour; Image; In Vitro; Intensive Care; Intervention; Ischemic Stroke; Joints; Magnetism; Medical Device; Modeling; Modernization; Neurologic; Neurology; Patients; Performance; Phase; Platinum; Procedures; Robotics; Roentgen Rays; Services; Site; Small Business Innovation Research Grant; Stroke; System; Technology; Thrombectomy; Time; Training; Underserved Population; United States; acute care; artery occlusion; base; certificate program; cost; cost effective; disability; health care disparity; improved; innovation; meetings; neurovascular; novel; operation; programs; prototype; standard of care; stroke therapy; stroke victims; thrombolysis; tool

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.

急性缺血性中风（AIS）是由神经血管系统中的血块引起的。目前，AIS仍然是第五 美国的主要死亡原因（美国）是神经疾病的主要原因。 AIS会 在2018年影响超过70万美国人，并在中风护理的最新进展之后仍然存在 死亡或严重残疾的机会为65％。到2030年，预计美国的AIS经济伯恩将 超过$ 180B。护理标准AIS疗法包括在中风发作4.5小时内使用溶栓 并尽早针对大容器闭塞的血栓切除术。但是，dospite血栓切除术的经过验证 价值，地理通道不良，早期血栓切除术仍然会导致很大的护理差异。 在美国，血栓切除术主要在综合中风中心（CSC）进行，为此 少于170。CSC认证与广泛的要求有关，包括获得高级 水平专业知识，24/7获得护理，专门的神经重症监护床，现场血栓切除术， CT/MR/CTA/MRA成像，并参与临床研究。因为考虑成本是相关的 通过建立和维护CSC，这些中心集中在人口稠密的城市中心附近， 可以提供更大的患者量。但是，结果是超过一半的美国人面对 转移时间长于1小时，对于许多人来说，转移延迟可能超过2小时。 为了帮助解决与所有美国人的平等血栓切除术的相同差距 委员会（与AHA/ASA合作）宣布了具有血栓切除术的中风中心（TSC） 认证计划于2018年1月1日，目的是创建一个地理分散的血栓切除术 - 功能强大的医院网络。但是，鉴于1）相关的构建TSC网络将是一个挑战 24/7 TSC计划人员配备的成本将很高，2）美国神经放射科医生少于3500 从和3）最高水平的专业知识可能会集中在大批量CSC中。 联合国及以后发明了一种小说且具有远程功能的机器人技术，可以增强关节 委员会的TSC计划。该技术的创新涉及使用兼容血管仪的使用 基于磁铁的工作站，以导航由独特的磁合金组成的神经血管工具，可以是 形成小的，可远程的指南和微心会员。结果是基于磁铁的机器人 平台比以前比以前小的40倍高40倍，这是第一次提供机器人解决方案 神经干预主义者。联合国和UP的团队包括领先的磁性，机器人，远程医疗和中风专家。 该项目的目的包括1）构建原型磁铁工作站，2）构建新型磁性指南 和微心会员，以及3）根据CTA/MRA评估血管幻像的设备性能 神经血管数据集。鉴于强大的FDA 510K谓词，预计该技术将受到调节 510k框架。 FDA预审会议将在第二阶段提案之前举行。