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.
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 for use 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 1,300 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.
The youngest patient to receive a SynCardia Heart was 9 years old; the oldest was 76 years old. The longest a patient has lived with a SynCardia Heart was nearly four years (1,374 days) before receiving a successful donor heart transplant Sept. 11, 2011.
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 more than 175 patients, accounting for over 100 years of support.