Tucson, Ariz. (PRWEB) October 31, 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 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.