TUCSON, Ariz., Sept. 13, 2012 /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 University of Kentucky (UK) Medical Center has successfully transplanted its first patient to receive the SynCardia temporary Total Artificial Heart. Zack Poe, 21, received his matching donor heart in July after five months of life with the Total Artificial Heart.
"When we first met Zack, we knew that he was the perfect candidate to receive the Total Artificial Heart as a bridge to transplant," said Dr. Charles Hoopes, director of the UK Transplant Center. "The Total Artificial Heart worked exactly as we had planned, and it allowed Zack to gain back his strength before receiving an appropriate donor heart."
Zack was first diagnosed with heart failure in January, when an echocardiogram revealed that his ejection fraction -- a measurement of how much blood the heart pumps out to the body during each beat -- was less than 10 percent. He was referred to UK Medical Center for advanced treatment options, and about a week and a half after his initial diagnosis, his liver began to fail.
In order to save Zack's life, UK Medical Center completed SynCardia's four-phase certification program in a record 25 days. Zach was implanted with the Total Artificial Heart on Feb. 10. Less than a month later, on March 5, he was discharged from the hospital to wait for a matching donor heart at home with his family using the Freedom® portable driver.
"The transplant team here at UK is second to none, and patients like Zack are living proof," said Dr. Jay Zwischenberger, surgeon-in-chief at UK HealthCare. "The fact that Zack and his family did not have to leave the state for treatment shows the great strides UK HealthCare has made in our ability to provide care for Kentuckians with even the most complex health issues."
Weighing 13.5 pounds, the Freedom portable driver is the world's first wearable power supply for the SynCardia Total Artificial Heart. 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. On April 24, SynCardia completed the minimum enrollment required by the clinical study.
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 270 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. 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.
SynCardia Wins Two Gold Stevies® at 2012 American Business Awards
On June 18, 2012, SynCardia was honored with two Gold Stevie® Awards at the 10th Annual American Business Awards. SynCardia won "Company of the Year – Health Products and Services" and "Most Innovative Company of the Year – up to 100 Employees." See the full list of SynCardia Awards & Recognition, which includes accolades from Forbes, Fast Company and more.
SOURCE SynCardia Systems, Inc.