Enabling rapid and effective stroke thrombectomy procedures from a Transradial approach: Combining introducer sheath, guide catheter, and distal access catheter into a single device.

PROJECT SUMMARY/ABSTRACT This proposal will improve the care of patients suffering from Acute Ischemic stroke (AIS). Catheter-based thrombectomy has been established as the standard treatment for AIS. Still, substantial limitations remain: 30% over conventional DACs), but struggle with navigation challenges in tortuous anatomies, with nearly half of procedures resulting in failure to navigate to the clot face. While they provide a major advance in DAC sizing, SuperBores have not been considered for TRA approaches due to their thick walls and stiff tips, precluding the ability to achieve optimized navigation or suction power from the radial approach. Our team discovered this pressing need after achieving acquisition by Medtronic of our previous SBIR-funded program via intensive interviews of 50+ physicians. In our successful Phase I project, we developed and tested our novel SuperBore thrombectomy system appropriate for TRA. Specifically, our “Wrist-to-Brain” thrombectomy system provides the distinct advantages of: (1) combining guide catheter and SuperBore DAC in a single catheter, (2) hyperthin walls enabled by our novel, proprietary liner, and (3) a highly trackable and kink resistant shaft that still fits within the radial artery in most patients. In this Phase II SBIR program, we propose a full, formal validation program guided by FDA testing criteria (Aim 1), followed by extensive benchtop, GLP animal, and cadaveric testing (Aim 2). This grant will enable us to complete all testing needed to submit for FDA clearance and begin marketing our novel and impactful Wrist-to-Brain thrombectomy system in order to improve the care of patients suffering from LVO AIS.