TUCSON, Ariz., Sept. 20, 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 the first patient to receive the SynCardia temporary Total Artificial Heart at Ankara University Heart Center in Turkey has been discharged from the hospital. The patient, 47-year-old Arif Sahin, is currently waiting for a matching donor heart with his family using the Freedom® portable driver to power his SynCardia Total Artificial Heart.
In 2011, Mr. Sahin suffered a severe heart attack that perforated one of his heart ventricles and caused extensive tissue damage. He underwent coronary bypass surgery at a local hospital, but during a follow-up visit several months later, an echocardiogram revealed he had a blood clot attached to his ventricle wall as well as a pseudoaneurysm.
After suffering from two strokes as a result of thromboembolism, Mr. Sahin was admitted to Ankara University Heart Center. When doctors took him into the operating room on May 7, the goal of surgery was to remove the clot and repair the pseudoaneurysm, but the SynCardia Total Artificial Heart was readied on stand-by just in case.
"An intra-operative examination revealed the extent of the cardiac damage to be inoperable and the size of the clot was overwhelming," said Prof. Dr. A. Ruchan Akar, Director of the Heart Transplant Program at Ankara University. "Although we were prepared for every possible scenario, once we opened his chest, it became clear that biventricular replacement with the SynCardia Total Artificial Heart was our only option to save this patient."
On July 10, Mr. Sahin became the second Total Artificial Heart patient in Turkey to be discharged from the hospital using the Freedom portable driver. The first patient, Omer Bayrak from Istanbul, has been enjoying life at home with the Freedom portable driver for more than a year.
"I am glad to say that we were able to help this patient," said Prof. Dr. Akar. "I'd like to thank my team for their excellent work and our surgical proctor, Dr. Latif Arusoglu, for his guidance. We now have a comprehensive mechanical circulatory support program thanks to the SynCardia Total Artificial Heart, which is the only solution for some of our patients."
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 four SynCardia Certified Centers in Turkey and the additional four Turkish hospitals currently undergoing the 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.
SOURCE SynCardia Systems, Inc.