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SynCardia's 50cc Total Artificial Heart Receives Two HUD Designations from the FDA for Destination Therapy and Pediatric Bridge to Transplant
Date:2/28/2013

TUCSON, Ariz., Feb. 28, 2013 /PRNewswire/ -- SynCardia Systems, Inc. (www.syncardia.com), 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.

(Photo: http://photos.prnewswire.com/prnh/20130228/LA68124)

"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
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SOURCE SynCardia Systems, Inc.
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