FDA Clears BioCardia’s Guide Catheter for Biotherapeutic Delivery System

The FDA granted BioCardia 510(k) clearance for its Morph DNA deflectable guide catheter, a device used to guide its Helix biotherapy delivery system during CardiAMP cell therapy delivery to the heart.

CardiAMP cell therapy is a procedure designed to treat heart failure. It employs the Helix delivery system to securely deliver a dosage of cells to the patient’s heart using a routine cardiac catherization procedure.

The guide catheter improves delivery of the cell therapy by using bidirectional deflection and enhanced fluoroscopic visibility.