FDA extends approval of Total Artificial Heart (Syncardia)to be used in destination therapy

SynCardia Systems, Inc., manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, has announced that the FDA has approved a Humanitarian Use Device (HUD) designation for the SynCardia temporary Total Artificial Heart to be used for destination therapy in addition to its current PMA approval as a bridge to transplant.The FDA approval letter of the HUD request designates the Total Artificial Heart for use in U.S. patients at risk of imminent death from non-reversible biventricular heart failure who are not eligible for cardiac transplant and have a specified body surface area.In the past the Total Artificial Heart had been limited to temporary use because U.S. patients couldn't leave the hospital with the 400-pound driver however, the new 13.5-pound Freedom portable driver makes patient discharge possible. The Freedom driver has made the Total Artificial Heart a viable option to support patients for the rest of their lives while allowing hospitals to make the best choice for each individual patient based on their medical needs. SynCardia is preparing a Humanitarian Device Exemption (HDE) to submit to the FDA.