Press Release:

TUCSON, Ariz. – Oct. 13, 2006 – October 15th marks the second anniversary of the FDA approval of the CardioWest™ temporary Total Artificial Heart (TAH-t). The TAH-t is the world’s first and still the only FDA approved temporary Total Artificial Heart. The artificial heart is used as a bridge to transplant for transplant eligible patients who are dying from end-stage biventricular heart failure.

TAH-t certified centers include many ranked by the US News and World Report 2006 Best Heart Hospital List: Cleveland Clinic, #1; Hospital University of Pennsylvania, #13; University Medical Center, Tucson AZ, #16; University of Michigan, #22; and Ohio State, #39. Next month, Barnes-Jewish in St. Louis, #10, will begin the TAH-t certification process. World class centers in Europe include: Bad Oeynhausen – Heart and Diabetes Center NRW, the German Heart Institute in Berlin, Groupe Hospitalier La Pitié-Salpêtrière in Paris, and Hôpital Guillaume et René Laennec in Nantes.

“We started the year with eight TAH-t certified centers. By the close of 2006 we will have more than doubled to 21 hospitals: ten in the U.S. and eleven in Europe. The TAH-t has been proven through 650 patient implants world wide,” explained Rodger Ford, President and CEO of SynCardia Systems, Inc., manufacturer of the TAH-t.

A New England Journal of Medicine paper published on August 26, 2004 (NEJM 2004; 351: 859-867), states that in the pivotal clinical study of the TAH-t, the one year survival rate for patients receiving the CardioWest TAH-t was 70 percent versus 31 percent for control patients who did not receive the device. One-year and five-year survival rates after transplantation among patients who had received a TAH-t as a bridge to human heart transplant were 86 and 64 percent.

The TAH-t is a modern version of the Jarvik-7 Artificial Heart that was implanted in Barney Clark in 1982. In the 1990s the device and technology moved to University Medical Center (UMC) in Tucson and was subsequently renamed the CardioWest™ temporary Total Artificial Heart. SynCardia Systems, Inc. was formed in 2001 by Marvin J. Slepian, M.D., Richard G. Smith, MSEE, CCE, and surgeon Jack Copeland, M.D.

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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