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凝块引起的。目前，AIS排名第五

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.