TITLE: A Novel Coaxial Deflectable Microcatheter for Rapid Navigation of Tortuous Vessels
INSTITUTION: Beth Israel Deaconess Medical Center
TECHNOLOGY TYPE: Therapeutic Device

DESCRIPTION: Microcatheters are used to access small vessels throughout the body to treat a wide variety of pathology, from traumatic hemorrhage to tumors. Selection of and navigation through these vessels can be challenging where there is complex anatomy or multiple targets. Such difficulties can result in added procedure time, unpredictable scheduling, increased radiation exposure, and poorer clinical outcomes. To address this, interventional radiologists exchange microcatheters, wires, and guide catheters of different shapes or stiffness.

Dr. Leo Tsai and his team have developed a microcatheter using a patent-protected novel coaxial design that allows active deflection of the microcatheter tip in both directions, while satisfying size requirements for general microvascular and neurovascular procedures and preserving the tracking and torqueing properties of conventional microcatheters. This obviates the need to stock or use different-shaped microcatheters, wires, or guide catheters. Other catheter deflection technologies cannot be configured to the required scale and length. Their design also lowers production costs to allow price-matching to competing high-end passive microcatheters. Their target users are general and neuro-interventional radiologists. The potential market size is $225M world-wide with rapid growth driven by advances in minimally-invasive therapies.

They have demonstrated proof of concept in a vascular testbed under a B-BIC Pilot grant, and more recently demonstrated superiority against predicate devices in a live animal model. Their specific aims are to achieve key elements in design verification, validation, and testing as part of an overall goal towards 510k approval. They intend to achieve 510k approval in two years and first in-human use.