The FDA has approved two Humanitarian Use Device (HUD) designations for the new SynCardia’s 50cc total artificial heart to be used for destination therapy and paediatric bridge to transplantation
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.
“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” said Michael Garippa, SynCardia chairman. “We are pleased that the FDA recognised the needs of these under-served 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.”