Arizona-based SynCardia Systems revealed that two of its Humanitarian Use Device (HUD) designations for the new 50cc Total Artificial Heart to be used for destination therapy and pediatric bridge to transplant has been approved by the US Food and Drug Administration.
The company added that the 50cc device is a smaller version of its 70cc SynCardia temporary Total Artificial Heart which had been approved by the FDA back in 2004.
The FDA approved HUD designation of the 50cc Total Artificial Heart for destination therapy on January 15 and is available for patients who are at a risk of imminent death from non-reversible biventricular heart failure while its use in treating biventricular heart failure in pediatric patients was approved on January 30.
"The 50cc Total Artificial Heart is designed to fit patients of smaller stature, including many women and adolescents who are too small to receive the 70cc Total Artificial Heart. We are pleased that the FDA recognized the needs of these underserved patient populations and was swift in approving the HUD designations. Together, the 70cc and 50cc Total Artificial Hearts will fit almost all adult men and women, and many adolescents, including patients with congenital conditions", SynCardia CEO and President, Michael Garippa said.