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SynCardia Systems, Inc.

Press Release:

Slovenia's First Total Artificial Heart Patient Receives Heart Transplant

Surgeon: Total Artificial Heart is "Best Solution" for Complicated Ventricular Septal Defect Involving Mitral Valve

 

Slovenia’s first SynCardia Total Artificial Heart patient Nikola Gašpic (middle) was bridged to a heart transplant on July 1, 2012. He is pictured post-transplant with his surgeon Dr. Ivan Knezevic and his wife Danica at University Medical Center (UMC) Ljubljana.

TUCSON, Ariz. – Oct. 4, 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 University Medical Center (UMC) Ljubljana has transplanted Slovenia's first patient to receive the SynCardia temporary Total Artificial Heart. The patient, 61-year-old Nikola Gašpic, received a matching donor heart on July 1, after 256 days of life with the Total Artificial Heart.

"We are very satisfied with the SynCardia Total Artificial Heart as a bridge to transplant," said Dr. Ivan Knezevic, director of the Transplant and Mechanical Circulatory Support Program at UMC Ljubljana. "For patients with a complicated ventricular septal defect involving the mitral valve, we think it is the best solution currently available. For this group of patients, the Total Artificial Heart is the only device which allows them to be discharged from the hospital until a suitable donor heart becomes available."

In October 2011, Mr. Gašpic suffered a heart attack that created a hole in the wall between his heart ventricles, known as a ventricular septal defect. He was admitted to the hospital, where he was placed on inotropes and implanted with an intra-aortic balloon pump (IABP), but his condition continued to deteriorate. 

To save Mr. Gašpic's life, on Oct. 19, 2011, doctors performed Slovenia's first implant of the SynCardia Total Artificial Heart as the only suitable treatment option. On Dec. 29, 2011, he was discharged from the 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 everything went so well," said Mr. Gašpic. "But, I have to mention that I felt better with the SynCardia Total Artificial Heart than I do now with my donor heart because the sound of the device pumping gave me a feeling of safety. I was in good health before I had my heart attack, and for me, everything after that has been like a dream. I am very grateful to the surgical and cardiology teams for their efforts in treating me medically, mentally and emotionally."

On July 18, UMC Ljubljana performed its second implant of the SynCardia Total Artificial Heart. The patient, a 52-year-old man suffering from cardiomyopathy and biventricular failure, was successfully bridged to a heart transplant.

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 Katarina Tepšic Štupica, PhD and Medica d.o.o., the distributor for the Total Artificial Heart in Slovenia, for their commitment and ongoing support of UMC Ljubljana.

CAUTION – The Freedom portable driver is an investigational device, limited by United States law to investigational use.

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About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the temporary Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.

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SynCardia Contact:
Janelle Drumwright, jdrumwright@syncardia.com, (520) 547-7463

 

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