Agile Devices, Inc. — Department of Health and Human Services SBIR Phase II: NHLBI

Description

Project Summary The goal of this project is to introduce a new microcatheter that will significantly improve an interventional radiologist s ability to navigate across small blood vesselsMicrocatheters are designed to reach small vascular targets from access points such as the femoral or radial arterieslocated up tocm awayInterventional radiologists use these devices to treat a wide variety of ailmentsfrom a traumatic vessel rupture to a hepatomaAccess and navigation of small vesselshowevercan be difficult in up toof all caseswhere there is challenging anatomy or when multiple targets are presentDifficulties in navigation can result in added procedure timeunpredictable schedulingincreased radiation exposureandin time critical processes such as a ruptured pseudoaneurysmpoorer clinical outcomesIn cases where navigation is challengingthe interventionalist can switch to microcathetersguidewiresor guide catheters with different shapes or stiffness to help with vessel selectionbut at additional cost and timeWe have developed a microcatheterthe Ausing a novel coaxial design that allows active deflection of the microcatheter tipwhile satisfying the size requirements for general microvascular and neurovascular procedures and preserving the tracking and torqueing properties of existing microcathetersThis would greatly enhance the operator s ability to navigate the vasculatureand reduce the need to stock and use passive devices with different shapesWe have provided proof of concept on a model testbed and also in vivoIn Phaseof this proposal we will focus on refinement our microcatheter prototypes to achieve a design freezeThis requires the development of an anatomically accurate vascular testbed that highlights the challenges encountered by the interventional radiologist and quantitative comparisons to commercially available microcatheters devices that will define the performance milestones of the AmicrocatheterIn Phasewe will focus on in vitro design verification and in vivo design validation testing versus predicate devices for ak applicationWe intend to achievek clearance withinyears and first in human use immediately afterwards