Tucson, Ariz. (PRWEB) 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.
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.”
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.
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, SynCardia's Total Artificial Heart is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. There have been more than 1,000 implants of the Total Artificial Heart, accounting for more than 250 patient years of life.
Similar to a heart transplant, SynCardia's 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 and does not require expensive anti-rejection medication, which can cause subsequent complications. It is the only device that 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.
SynCardia Ranked #20 Among World's 50 Most Innovative Companies
In March 2011, Fast Company magazine ranked SynCardia #20 in its annual list of the "World's 50 Most Innovative Companies" for "giving mobility to artificial heart recipients." Weighing 13.5 pounds, SynCardia's Freedom® portable driver is the world's first wearable driver designed to power the Total Artificial Heart both inside and outside the hospital. 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.