1st SynCardia Total Artificial Heart Patient
Discharged from Ege University in Turkey
Former Professional Soccer Player Waits for Matching Donor Heart at Home
Using the Freedom® Portable Driver to Power His Total Artificial Heart
TUCSON, Ariz. – Nov. 1, 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 for the first time in Izmir, Turkey, a patient
implanted with the SynCardia temporary Total Artificial Heart has been discharged from the hospital. On Sept. 26, 57-year-old Nurullah Balik was discharged from Ege University Hospital to wait for a matching donor heart at home using the Freedom® portable driver to power his Total Artificial Heart.
“I am very happy to return home,” said Mr. Balik, a former professional soccer player. “Thanks to the Freedom portable driver, now I can enjoy my daily routine in the town where I live instead of in the hospital.”
In 2002, Mr. Balik suffered a heart attack and received several stents. Five years later, he was diagnosed with congestive heart failure. Over time, his condition continued to deteriorate and in May 2012, he was diagnosed with heart failure affecting both sides of his heart (biventricular failure). In addition, three of his four heart valves were leaking. He was admitted to the hospital on July 17.
“This patient was in severe biventricular failure with valvular insufficiency,” said Prof. Dr. Mustafa Ozbaran, head of the Transplant and Assist Device Program. “The best option for our patient was the SynCardia Total Artificial Heart.”
On Aug. 13, doctors removed Mr. Balik’s failing heart and replaced it with the SynCardia Total Artificial Heart. He was able to leave the hospital just 44 days later, setting a new record for the fastest discharge of a Total Artificial Heart patient in Turkey.
Ege University Hospital is Turkey’s leading transplant center, having performed more than 170 heart transplants and implanted more than 100 long-term mechanical circulatory support devices. The hospital performed Turkey’s first implant of the SynCardia Total Artificial Heart on Sept. 30, 2010.
Weighing approximately 6 kg (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.
SynCardia recognizes and thanks Ufuk Yaranli and Natura Medikal Urunler Ltd., the Turkish distributor for the Total Artificial Heart, for their commitment and ongoing support of the five SynCardia Certified Centers in Turkey and the additional three Turkish hospitals currently undergoing SynCardia’s four-phase certification process.
CAUTION – The Freedom portable driver is an investigational device, limited by United States law to investigational use.
SynCardia Systems, Inc. in Tucson, Arizona is the privately-held owner and 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 SynCardia Total Artificial Heart is currently approved as a bridge to transplant for people suffering from end-stage biventricular heart failure in which both ventricles can no longer pump enough blood for a person to survive.
More than 1,350 implants of the SynCardia Total Artificial Heart accounts for over 400 patient years of life on the device. Since January 2011 more than 400 SynCardia Hearts have been implanted.
SynCardia Systems also manufactures the Freedom® portable driver, which powers the SynCardia Heart while allowing clinically stable patients to leave the hospital to live at home and in their communities. The wearable Freedom driver has been used by over 200 patients, accounting for over 120 years of support.