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SynCardia Systems, Inc.

Press Release:

1st Pediatric Total Artificial Heart Patient Discharged Home Using Freedom® Portable Driver

18-Year-Old Jordan Merecka Leaves Texas Children's Hospital to Wait for Matching Donor Heart at Home Wearing Portable Power Supply

TJordan Merecka, 18, is the first pediatric SynCardia Total Artificial Heart patient to be discharged from Texas Children's Hospital to wait for a matching donor heart at home using the Freedom® portable driver. Jordan, pictured with his mother Suzanne, is participating in the FDA clinical study of the Freedom driver, a wearable power supply for SynCardia’s Total Artificial Heart. Jordan Merecka, 18, is the first pediatric SynCardia Total Artificial Heart patient to be discharged from Texas Children's Hospital to wait for a matching donor heart at home using the Freedom® portable driver. Jordan, pictured with his mother Suzanne, is participating in the FDA clinical study of the Freedom driver, a wearable power supply for SynCardia’s Total Artificial Heart. TUCSON, Ariz. – Sept. 7, 2011 – SynCardia Systems, Inc., manufacturer of the SynCardia temporary Total Artificial Heart, announced today that Texas Children's Hospital in Houston has discharged its first pediatric Total Artificial Heart patient to wait for a matching donor heart at home. On Aug. 31, 18-year-old Jordan Merecka left the hospital using the Freedom® portable driver, a wearable power supply for his Total Artificial Heart.

"Having Jordan home again is the best gift in the world," said Suzanne Merecka, Jordan's mother. "The artificial heart was a blessing when he needed it desperately and his father and I are glad that Texas Children's could offer a life-saving option when things looked very grim. He still has a heart transplant in his future, but the artificial heart has helped him grow stronger. He will be ready when the time comes."

Jordan is participating in the FDA-approved Investigational Device Exemption (IDE) clinical study of the Freedom portable driver. Weighing 13.5 pounds, the Freedom driver is the first U.S. portable driver designed to power the Total Artificial Heart both inside and outside the hospital. 

Jordan was born with multiple congenital heart defects, including his heart on the wrong side of his chest (dextrocardia) and his heart vessels backwards (corrected transposition of the great arteries). In April 2011, Jordan was admitted to the hospital after he progressed to end-stage biventricular failure while awaiting a heart transplant. In May, all of his organs began to fail and he was placed on a ventilator. To save Jordan's life, on May 22, his doctors performed the hospital's first implant of SynCardia's Total Artificial Heart.

"It was always our plan to move Jordan to the Freedom driver as soon as he was strong enough and had met all the protocol guidelines," said Dr. David L.S. Morales, pediatric cardiovascular surgeon at Texas Children's Heart Center and associate professor of surgery and pediatrics at Baylor College of Medicine (BCM), who implanted the Total Artificial Heart. "Jordan will gain a morale boost by being out of the hospital, enjoying a more active teen life as he waits for heart transplantation."

CAUTION – The Freedom® portable driver is an investigational device, limited by United States law to investigational use.

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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 SynCardia 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.

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SynCardia Contact:
Janelle Drumwright, jdrumwright@syncardia.com, (520) 547-7463

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