TUCSON, Ariz. – SynCardia Systems, Inc. (www.syncardia.com),
manufacturer of the SynCardia temporary Total Artificial Heart, announced today
that on Dec. 29, 2011, University Medical Center (UMC) Ljubljana discharged
Slovenias first Total Artificial Heart patient, 61-year-old Nikola Gašpi?, to
wait for a matching donor heart at home using the Freedom®
portable driver.
“The Total Artificial Heart was the perfect solution to
bridge this patient to a transplant because he had a ventricular
septal defect (VSD). For VSD, there are no other effective treatments,”
said Dr. Ivan Knezevic, Director of the Transplant and Mechanical Circulatory
Support Program in the Department of Cardiovascular Surgery at UMC Ljubljana.
Previously healthy, Mr. Gašpi? suffered a heart attack that
created a hole in his septum (VSD), which is the wall that separates the left
and right ventricles of the heart. He was placed on inotropes and implanted
with an intra-aortic balloon pump (IABP), but he continued to deteriorate. To
save his life, on Oct. 19, 2011, doctors implanted the Total
Artificial Heart as the only suitable treatment option.
The implant surgery was performed by Dr. Knezevic and
proctored by experienced Total Artificial Heart surgeon Dr. Latif Arusoglu. It
was the first implantation of SynCardias Total Artificial Heart in
southeastern Europe.
UMC Ljubljana is Slovenias biggest hospital and its
only transplant center. Each year, UMC Ljubljana performs 18-19 heart
transplants and approximately 1,000 open heart surgeries. It is the first and
only SynCardia
Certified Center in Slovenia.
Weighing approximately 6 kg, the Freedom portable driver is
the worlds 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 Katarina Tepši? Štupica, PhD
and Medica d.o.o., the Slovenian distributor for the Total Artificial Heart,
for their commitment and on-going support of UMC Ljubljana.
About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the worlds
first and only FDA, Health Canada
and CE approved Total Artificial Heart. Originally used as a permanent
replacement heart, SynCardias 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 950 implants of the Total Artificial Heart,
accounting for more than 230 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 and does not require expensive anti-rejection medication,
which can cause subsequent complications. It is the only device that
provides immediate, safe blood flow of up to 9.5 liters per minute through both
ventricles. This high volume of safe blood flow helps speed the recovery of
vital organs, helping make the patient a better transplant candidate.
Posted by Sean Fenske, Editor-in-Chief, MDT
