TUCSON, Ariz., Sept. 7, 2011 /PRNewswire/ -- SynCardia Systems, Inc. (www.syncardia.com), 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.
"When I get home, I hope to be able to go fishing in the ponds in my neighborhood, hang out with my friends again, just relax, sit in my favorite chair," said Jordan. "I'm going to enroll in college classes while I'm waiting at home for my transplant."
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.
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 Total is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. More than 950 implants account for more than 230 patient years of life.
Similar to a heart transplant, SynCardia's Total Artificial Heart replaces both failing heart ventricles and the four heart valves. It is the only device that eliminates the symptoms and source of end-stage biventricular failure. The Total Artificial Heart provides immediate, safe blood flow of up to 9.5 liters per minute through both ventricles. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.
In March 2011, Fast Company magazine ranked SynCardia #20 among the World's 50 Most Innovative Companies "for giving mobility to artificial heart recipients." Also in March, the longest running health and wellness series on public television, "Healthy Body, Healthy Mind," produced a 30-minute program featuring SynCardia's Total Artificial Heart. View here
For additional information, please visit: http://www.syncardia.com
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|SOURCE SynCardia Systems, Inc.|
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