The US Food and Drug Administration (FDA) has granted humanitarian use device (HUD) designation to SynCardia Systems to use its temporary Total Artificial Heart as a destination therapy, in addition to current pre market application (PMA) approval as a bridge to transplant.
The FDA approval letter of the HUD request designates the Total Artificial Heart for use in US 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 (BSA) of = 1.7m2’.
SynCardia chairman, CEO and president Michael Garippa said the HDE (Humanitarian Device Exemption) designation will allow the Total Artificial Heart to save the lives of up to 4,000 US patients each year who are not eligible for transplant.
"Historically, the Total Artificial Heart had been limited to temporary use because U.S. patients couldn’t leave the hospital with the 400-pound driver," Garippa added.
"However, the new 13.5-pound Freedom portable driver has leveled the playing field in mechanical circulatory support."
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.
SynCardia’s Total Artificial Heart is CE approved for use in Europe and is undergoing an FDA-approved investigational device exemption (IDE) clinical study in the US.