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SynCardia Systems, Inc.

Press Release:

Destination Therapy with the SynCardia Total Artificial Heart Described in Case Study by EKN Duisburg

Ineligible for a donor heart transplant, the 74-year-old man who could not be supported by an LVAD now lives a normal life with a SynCardia Total Artificial Heart powered by the Freedom® portable driver.

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TUCSON, Ariz. – June 19, 2014 – A 74-year-old German patient who is not eligible for a donor heart transplant has lived for more than a year on the SynCardia temporary Total Artificial Heart powered by the Freedom® portable driver, demonstrating the device’s use for permanent use, also known as destination therapy.

“A first step beyond traditional boundaries: destination therapy with the SynCardia Total Artificial Heart” was authored by Dr. med Sotirios Spiliopoulos, department of surgical therapy of end-stage heart failure and mechanical circulatory support at the Heart and Vascular Center EKN Duisburg in Germany. Prof. Dr. Reiner Körfer and Prof. Dr. Gero Tenderich were also authors. The article is in the June 2014 issue of the journal Interactive Cardiovascular and Thoracic Surgery.

The patient, admitted for infiltrative cardiomyopathy, experienced kidney failure and heart failure despite therapy to reverse his condition. He was implanted with a SynCardia Heart, which is designed to eliminate the source of end-stage biventricular heart failure. He also fully recovered his renal function.

At the end of the “Case Presentation” section of the paper, the authors wrote, “Compared with baseline, quality of life, measured by the Minnesota living with Heart Failure Questionnaire, improved (45 vs 93). The patient is now able to perform everyday activities (NYHA I–II).”

In the last paragraph of the paper, the authors wrote, “Despite short duration of support, this case demonstrates that therapy with a SynCardia TAH (Total Artificial Heart) has the potential to expand beyond BTT (bridge to transplant) towards DT (destination therapy) for patients ineligible for transplantation. Besides the well-known effect of end-organ recovery…quality of life obviously improves. However, in this early stage, it is crucial to carefully select the appropriate patient.”

The SynCardia Total Artificial Heart is the world’s first and only Total Artificial Heart approved by the FDA, Health Canada and CE 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.

 

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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 SynCardia 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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