TEXT: The 50cc SynCardia Total Artificial Heart is designed for use in patients of smaller stature, including women and adolescents. It has been designated as a Humanitarian Use Device (HUD) by the FDA for destination therapy and pediatric bridge to transplant. Prior to clinical use, a Humanitarian Device Exemption (HDE) application for each indication must be approved by the FDA.  (PRNewsFoto/SynCardia Systems, Inc.)