1st Turkish Total Artificial Heart Patient
Discharged Using Freedom® Portable Driver
45-Year-Old Father of Three Discharged from Florence Nightingale Hospital in Istanbul
to Wait for Matching Donor Heart at Home with Family
TUCSON, Ariz. – June 22, 2011 – SynCardia Systems, Inc. manufacturer of the SynCardia temporary Total Artificial Heart, announced today that Florence Nightingale Hospital in Istanbul has discharged Turkey's first Total Artificial Heart patient to wait for a matching donor heart at home using the Freedom® portable driver. Weighing 13.5 pounds, the Freedom driver is the world's first wearable portable driver designed to power SynCardia's Total Artificial Heart both inside and outside the hospital.
"Initially, we had concerns about switching our patient to the Freedom driver because he is really a big guy," said surgeon Prof. Dr. Deniz Suha Kucukaksu. "However, our patient experienced no differences with this wearable driver. We are excited to be able to discharge him with his Total Artificial Heart. The Freedom driver is so powerful that he can live a near normal life outside of the hospital while waiting for transplantation under safe conditions."
Omer Bayrak, 45, had been suffering from congestive heart failure since 2001. Four years ago, he underwent cardiac resynchronization therapy and received an implantable cardioverter-defibrillator (ICD). Last year, he was hospitalized 11 times for inotropic support.
For 15 days prior to receiving SynCardia's Total Artificial Heart, Mr. Bayrak had been in the cardiac intensive care unit. He was on the urgent list for heart transplantation but his cardiac function continued to worsen. As a result, he became the hospital's first patient to receive SynCardia's Total Artificial Heart.
"I can do almost everything with my Freedom driver," said Mr. Bayrak, who was discharged from the hospital on May 20. "Although I have no biological heart, I still have emotions. Before this illness period, I was against organ donation, but now I understand the importance of it."
The Freedom portable 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 on-going support of Florence Nightingale Hospital.
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, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for people suffering from end stage heart failure affecting both sides of the heart (biventricular failure). More than 400 SynCardia Total Artificial Heart implants have been performed since January 2011. The SynCardia Heart has provided almost 130,000 patient days of support from nearly 1,300 implants. The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 76 years old.
Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves. It is the only device that eliminates the symptoms and source of end stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at 97 SynCardia Certified Centers worldwide with 39 others in the process of certification.
The Total Artificial Heart provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high volume of blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.