Helix Biotherapeutic Delivery - System Overview

Local transendocardial delivery for biotherapeutic delivery has become important in numerous cell, gene, and protein therapy investigations to treat a variety of cardiovascular indications. Preclinical and clinical studies are currently underway using the BioCardia Helical Infusion System to deliver genes and cells to treat heart failure, myocardial infarction, ischemia, and cardiac conduction disorders. This mode of delivery provides for a catheter located within the left ventricular space with a penetrating element for delivery through the endocardium to a depth within the myocardium.

BioCardia’s Helical Infusion Catheter is a catheter with a small hollow, distal corkscrew needle which may be rotated into tissue to provide active fixation during drug delivery. This system provides a means to have fixation to the beating heart wall, uses simplified fluoroscopic imaging, crosses the aortic arch and valve safely over a guide wire with BioCardia's unique FDA cleared steerable Morph guide catheters, and provides the operator with three degrees of freedom to maximize operator control (deflection and rotation of the Morph guide and reach to the ventricular wall with the Helix catheter).