The FDA has approved two humanitarian use device (HUD) designations for Syncardia System’s 50cc Total Artificial Heart to be used for destination therapy and pediatric bridge to transplant.
The 50cc device is a smaller version of the 70cc SynCardia temporary Total Artificial Heart, which received FDA approval as a bridge to transplant in 2004.
To be eligible for destination therapy, patients must be at risk of imminent death from nonreversible biventricular heart failure, not eligible for cardiac transplant and have a body surface area between 1.2 m2 and 1.79 m2. For be used for the pediatric treatment of biventricular heart failure, patients must have sufficient body surface area to accommodate the device (between 1.2 m2 and 1.7 m2).
A HUD is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the U.S. per year. Tucson, Ariz.-based Syncardia reported the its next step is the obtain FDA approval for a Humanitarian Device Exemption application for each indication of the 50cc Total Artificial Heart.