Rapid Navigation of Tortuous Vasculature with a Novel Steerable Coaxial Microcatheter

Project Summary The goal of this project is to commercialize a new steerable microcatheter, the Angler™, which will significantly improve an interventional radiologist’s ability to navigate across small blood vessels. Microcatheters are designed to reach small vascular targets from access points such as the femoral or radial arteries, located up to 150 cm away. Interventional radiologists use these devices to treat a wide variety of ailments, from a traumatic vessel rupture to a hepatoma. Access and navigation of small vessels, however, can be difficult in up to 45 % of all cases, where there is challenging anatomy or when multiple targets are present. Difficulties in navigation can result in added procedure time, unpredictable scheduling, increased radiation exposure, and, in time-critical processes such as a ruptured pseudoaneurysm, poorer clinical outcomes. In cases where navigation is challenging, the interventionalist can switch to microcatheters, guidewires, or guide catheters with different shapes or stiffness to help with vessel selection, but at additional cost and time. We have developed the Angler™ using a novel coaxial design that allows active deflection of the microcatheter tip, while satisfying the size requirements for general microvascular and neurovascular procedures and preserving the tracking and torqueing properties of existing microcatheters. This would greatly enhance the operator’s ability to navigate the vasculature, and reduce the need to stock and use passive devices with different shapes. The capabilities of this device have been proven versus existing microcatheters through independent bench testing and two separate animal studies with interventional radiologists. Following 510(k) clearance, Agile Devices will perform all FDA required process validations before commencing human use builds. We will also develop two new line extensions (an 0.027” I.D. high-flow version and a 0.0165” I.D. neuro version) through design freeze. These will expand usage of our technology into additional peripheral vascular and cancer applications and into neurovascular procedures.This project seeks to improve a physician’s ability to perform minimally invasive treatment of many diseases, from bleeding aneurysms to cancer. We are introducing a new device that will enable doctors to reach small blood vessels more easily and precisely. This will improve targeting and allow faster treatments, resulting in improved clinical outcomes at lower cost.