Press Release:

TUCSON, Ariz. – May 16, 2006 – Berlin Heart AG, maker of the EXCOR® Ventricular Assist Devices for children and adults, has received the CE Mark to market a modified version of its Excor Mobile Driving Unit with the CardioWest™ TAH-t in Europe.

The TAH-t is the only FDA, Health Canada and CE approved Artificial Heart in the world. The Artificial Heart is a bridge to transplant for patients with end-stage biventricular heart failure who are waiting for a donor human heart. The pneumatic drivers provide air pulses that make the TAH-t pump blood much like a human heart.

The new Excor TAH-t portable driver is about the size of an attaché case and weighs only 20 pounds. It is designed for use following TAH-t implant surgery, by stable patients. The portable driver allows stable patients to recover at home, which speeds recovery, improves quality of life and dramatically lowers costs. In addition, the portable driver enables patients to leave home to shop, and for some, to travel.

The older, 400 pound, washing machine sized driver, “Big Blue,” is used both in the operating room and the hospital. Using “Big Blue” to power the TAH-t requires patients to remain in the hospital until a donor heart is found. This could be months, and in Europe, sometimes up to two years.

“The portable driver gives patients more freedom to enjoy a better quality of life… and because many patients recuperate in the comfort of their homes, hospitalization costs for this portion of their recovery are eliminated,” explained Cardiologist Marvin Slepian, M.D., Chairman of SynCardia.

A New England Journal of Medicine paper published in Aug. 2004, states that, in the pivotal clinical study of the TAH-t, the one year survival rate for patients receiving the CardioWest temporary Total Artificial Heart was 70 percent versus 31 percent for control patients who did not receive the device.

SynCardia has applied for its own CE mark which will allow the company to market its TAH-t with the Excor TAH-t in Europe, and anticipates approval in Q2. The Excor driver is not approved by the FDA for use in the US.

The TAH-t is a modern version of the Jarvik-7 Artificial Heart that was implanted in Barney Clark in 1982. In the 1990’s the device and technology moved to University Medical Center (UMC) in Tucson and was subsequently renamed the CardioWest™ temporary Total Artificial Heart. Budget cutbacks at UMC came close to stopping the study of this technology. To save the TAH-t, SynCardia Systems, Inc. was formed in 2001 by Marvin J. Slepian, M.D., Richard G. Smith, MSEE, CCE, and cardiovascular 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