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SynCardia Systems, Inc.

Press Release:

3 Pediatric Centers that Offer Total Artificial Heart
Named in Top 10 for "Best Children's Hospitals"

U.S News & World Report Ranks CHOP #2, Texas Children's #3
and Cincinnati Children's #9 for Cardiology and Heart Surgery

 

TUCSON, Ariz. – June 26, 2012 – SynCardia Systems, Inc., manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that U.S. News & World Report has named three pediatric centers that offer the SynCardia temporary Total Artificial Heart among the nation's Top 10 "Best Children's Hospitals" for Cardiology and Heart Surgery in its annual list. The Children's Hospital of Philadelphia (CHOP) was ranked #2, Texas Children's Hospital was ranked #3 and Cincinnati Children's Hospital Medical Center was ranked #9.

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In May 2011, Texas Children's became the first pediatric hospital in the world to implant the Total Artificial Heart. The patient, 17-year-old Jordan Merecka, was born with a "reversed" heart (dextrocardia) and his heart vessels backwards (corrected transposition of the great arteries). In August 2011, he became the first pediatric Total Artificial Heart patient to be discharged from the hospital using the Freedom® portable driver, the world's first wearable power supply for the Total Artificial Heart. Jordan received his heart transplant on Oct. 20, 2011. This August, he will begin his first day of classes in the Maritime Systems Engineering program at Texas A&M.

"One of the most impressive things about the Total Artificial Heart is it can take the most ill patients who are in multi-system organ failure, reverse the process and recuperate these patients for whom other forms of mechanical therapy may fall short," said Dr. David L.S. Morales, Jordan's surgeon and the new chief of pediatric cardiothoracic surgery at Cincinnati Children's. "The Total Artificial Heart has opened the flood gates in respect to the treatment possibilities for a quickly growing population of children in heart failure, including adolescents suffering from chronic rejection of their transplanted heart, end-stage heart failure accompanied by multiple congenital defects and a chronic failed Fontan circulation."

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In January 2012, CHOP became the first hospital to implant the Total Artificial Heart into a pediatric patient who was born with only one functional heart ventricle and was suffering from a failed Fontan procedure. The teenager was bridged to a transplant with the Total Artificial Heart in March 2012.

"Pediatric patients who have undergone multiple operations often have no surgical options remaining other than cardiac transplantation," said Dr. J. William Gaynor, an attending cardiothoracic surgeon at CHOP. "When the SynCardia Total Artificial heart is compared to ventricular assist devices, there is simply no other device which offers the same improvement in cardiac output, the same flexibility for complex congenital heart disease and the same opportunity to improve the condition of these patients and their long-term survival."

In March, Phoenix Children's Hospital bridged its first patient to transplant with the Total Artificial Heart. This marked three consecutive pediatric patients bridged to transplant with the Total Artificial Heart during a six-month period ending March 2012.

The Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.

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 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.

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

 

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