Piraeus Medical, Inc.

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: <50% of Patients Achieve First-pass Clot Clearance, the Best Predictor of Good Neurological Outcome, Largely Due to Shortcomings in the Approach (transfemoral Access [tfa]) and the Current Catheters Used to Aspirate Clots. Given the Advanced Age of Many or Most Thrombectomy Candidates, Highly Tortuous Vessels Are Frequently Encountered When Traversing From the Femoral to Carotid Territories. It Has Been Shown That Substantial Tortuosity Leads to Worse Outcomes in Tfa Procedures. Thus, Many Leading Interventionalists Have Proposed Transradial Access (TRA) in Place of Transfemoral Access. Tra Is Already the Preferred Access Site for the Vast Majority of Interventional Cardiology Procedures, Given Low Rates of Bleeding Complications and Ready Access to the Coronary Circulation. the Radial Site Also Provides Ready Access to the Cerebral Vasculature, Bypassing Tortuosity Along the Aortic Arch, Descending Aorta, and Ilio-femoral System. However, Neurointerventionalists Who Use Tra Are Stuck Employing Femoral Guide Sheaths (such as the Ballast or Neuron Max), Which Are Not Designed for the Radial-to-intracranial Navigation and Which Have Safety Concerns Due to the Vasospasm or Radial Artery Occlusion That Can Result From Their Imperfect Adaptation to Tra. a Parallel Advancement in Neurointervention Is That of Superbore Distal Access Catheters (DACS) Used to Efficiently Pull Out Clots From Arteries of Patients Suffering From Ais. These Superbore Dacs Provide Large Lumens (increasing Suction by >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.