The FDA has approved a humanitarian use device (HUD) designation for SynCardia Systems' temporary Total Artificial Heart to be used for destination therapy in addition to its current premarket approval as a bridge to transplant.
This will allow the Total Artificial Heart to be used in up to 4,000 U.S. patients each year who are not eligible for transplant, according to Michael Garippa, SynCardia's chairman, CEO and president.
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 body surface area of equal or greater than 1.7m2.” Tucson, Ariz.-based SynCardia is preparing a humanitarian device exemption to submit to the FDA.
Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart received FDA approval in 2004 as a bridge to transplant for transplant-eligible patients dying from end-stage biventricular heart failure.
The Freedom portable driver is a wearable power supply for SynCardia’s Total Artificial Heart. It is CE approved for use in Europe and undergoing an FDA-approved investigational device exemption clinical study in the U.S.