Press Release:

Largest Hospital in Northern Europe Begins Certification Training
on CardioWest™ Temporary Total Artificial Heart

TUCSON, Ariz. – Sept. 19, 2007 – On August 27 and 28, the heart transplant team from Sahlgrenska University Hospital in Gothenburg, Sweden, which included Dr. Lars Wiklund, chief of cardiothoracic surgery, and cardiothoracic surgeon Dr. Ulf Kjellman, received the first phase of certification training in Berlin to implant the CardioWest™ temporary Total Artificial Heart (TAH-t).

Sahlgrenska University Hospital is the largest hospital in northern Europe, with more than 2,700 beds and 140 departments. Sweden will join Germany, France and Austria as the fourth European country with a hospital certified to implant the only FDA and CE approved temporary artificial heart in the world.

Today there are 22 TAH-t certified centers, 11 in the U.S. and 11 in Europe. Sahlgrenska University Hospital is the 12th hospital in Europe, and the 25th center in the world to complete the first phase of TAH-t certification training.

The CardioWest TAH-t is approved as a bridge-to-transplant for patients dying from end-stage biventricular failure. Their survival depends on receiving a donor heart, or a TAH-t as a bridge-to-transplant.

A pivotal clinical study of the TAH-t published in the New England Journal of Medicine (NEJM 2004; 351: 859-867) showed that 79 percent of patients receiving the TAH-t survived to transplant, the highest survival rate for any device in the world.

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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, SynCardia's 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.

SynCardia Ranked #20 Among World's 50 Most Innovative Companies
In March 2011, Fast Company magazine ranked SynCardia #20 in its annual list of the "World's 50 Most Innovative Companies" for "giving mobility to artificial heart recipients." Weighing 13.5 pounds, SynCardia's Freedom® portable driver is the world's first wearable driver designed to power the Total Artificial Heart both inside and outside the hospital. 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.

For additional information, please visit: http://www.syncardia.com
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Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660

 

 

*The SynCardia temporary Total Artificial Heart was formerly known as the
SynCardia temporary CardioWest™ Total Artificial Heart.

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