SynCardia Systems, Inc.'s 50cc Total Artificial Heart Receives Two HUD Designations From the FDA for Destination Therapy and Pediatric Bridge to Transplant

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.

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"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 the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure). There have been more than 1,100 implants of the Total Artificial Heart, accounting for more than 300 patient years of life.

Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves, eliminating the symptoms and source of end-stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at SynCardia Certified Centers. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

Forbes Ranks SynCardia #69 Among "America's Most Promising Companies"
In its February 2013 issue, Forbes selected SynCardia as one of "America's Most Promising Companies" for the second consecutive year. On the list of 100 privately held, high-growth companies with bright futures, SynCardia was selected #69, moving up eight spots from its #77 ranking last year. To see the full list of SynCardia Awards & Recognition go to: http://www.syncardia.com/SynCardia/syncardia-awards-and-recognition.html.

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SOURCE SynCardia Systems, Inc.