Posted by Michael Wonder on 04 Feb 2022
BioCardia receives FDA breakthrough device designation for CardiAMP cell therapy system for heart failure
3 February 2022 - BioCardia today announced that the U.S. FDA has granted breakthrough device designation for the CardiAMP Cell Therapy System for the treatment of heart failure.
It is believed to be the first cardiac cell therapy to receive FDA breakthrough device status.
CardiAMP Cell Therapy uses a patient’s own (autologous) bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure.
