Home » FDA Clears BioCardia’s Guide Catheter for Biotherapeutic Delivery System
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.
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