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.
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 SynCardia 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.
Janelle Drumwright, firstname.lastname@example.org, (520) 547-7463