BioCardia, Inc. announced the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Morph® DNA deflectable guide catheter used to guide the Helix™ Biotherapeutic Delivery System during CardiAMP™ cell therapy delivery in the heart. The Morph DNA deflectable guide catheter is designed to enhance procedural control of therapeutic catheters, such as the Helix system, during delivery of cell therapy. It is intended to provide superior ease of use through bidirectional deflection, reduced torque build up or whip, enhanced fluoroscopic visibility, and improved ergonomics. Helically-arranged pull-wires in the device, resembling the double helix of a DNA strand, increase catheter stability, rendering it virtually whipless around curves and within the heart. The device also features a new handle design with an adjustable brake for finer catheter control during procedures.