The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the BioCardia’s CardiAMP® Cell Therapy System designed for the treatment of heart failure. Heart Failure (HF) is a complex, progressive clinical syndrome that affects the structure of the heart and the muscles responsible for pumping blood. CardiAMP is believed to be the first cardiac cell therapy to receive FDA Breakthrough Device status and is designed to stimulate the body’s natural healing response, provoking a beneficial paracrine reaction that can repair the damaged heart. CardiAMP further uses autologous bone marrow cells that are delivered to the heart in a minimally invasive, catheter-based procedure. The FDA’s Breakthrough Device Designation is reserved for the approval of novel devices or device-led combination products (a combination of drugs, devices, or biological products) that provide for more effective treatment or diagnosis of life-threatening debilitating diseases and conditions. BioCardia is a California-based developer of stem cell therapies for the treatment of cardiovascular and pulmonary diseases.
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