SynCardia's 50cc Total Artificial Heart Receives Two HUD Designations from the FDA for Destination Therapy and Pediatric Bridge to Transplant
Together, SynCardia's 70cc and 50cc Total Artificial Hearts Will Fit Almost All Adult Men and Women, and Many Adolescents
TUCSON, Ariz. – Feb. 28, 2013 – SynCardia Systems, Inc., manufacturer of the world’s first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that the U.S. Food and Drug Administration (FDA) has approved two Humanitarian Use Device (HUD) designations for the new 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.
“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/CEO/President. “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.”
- HUD for Destination Therapy:
On Jan. 15, the FDA granted a HUD designation for the 50cc Total Artificial Heart to be used for destination therapy. To be eligible, patients must be at risk of imminent death from non-reversible biventricular heart failure, not eligible for cardiac transplant and have a Body Surface Area (BSA) between 1.2 and 1.79m2.
- HUD for Pediatric Bridge to Transplant:
On Jan. 30, the FDA granted a HUD designation for the 50cc Total Artificial Heart to be used for the treatment of biventricular heart failure in pediatric patients with a BSA that can sufficiently accommodate the device (i.e. between 1.2 and 1.7m2).
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 United States per year. The next step is for the FDA to approve a Humanitarian Device Exemption (HDE) application for each indication of the 50cc Total Artificial Heart.
Once approved, the HDEs will allow up to 4,000 U.S. patients annually to receive the 50cc Total Artificial Heart as destination therapy, and an additional 4,000 pediatric patients to receive the device as a bridge to transplant.
About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the temporary Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.
Janelle Drumwright, firstname.lastname@example.org, (520) 547-7463