German and French CardioWest Artificial Heart Patients Enjoy a Better Quality of Life Than Americans.

TUCSON, Ariz. -- Although the CardioWest[TM] temporary Total Artificial Heart (TAH-t) was designed, engineered and is privately owned and manufactured in the United States, it is the Europeans who are being discharged to recover at home while Americans with the TAH-t are confined to the hospital. These patients are waiting for donor hearts for transplant.

Since the start of the 2003 clinical study of the portable driver, stable patients in Europe have been discharged to recover at home. The driver provides precisely calibrated pulses of air that power the TAH-t. The portable driver received the CE mark for use throughout Europe on July 17, 2006.

"We can describe the quality of life of patients supported by the portable driver as near normal. They are very active. They can go shopping, drive in cars, they can go for holidays, for vacations and so on. Recovery at home eliminates hospitalization costs for this part of their care," said Dr. Aly El-Banayosy, who pioneered the clinical study of the portable driver at the Heart and Diabetes Center NRW in Bad Oeynhausen, Germany.

"The best part of the portable driver is that I can live free, free from the hospital, free from the doctors," said TAH-t patient Hans Walter Thrun, who lives a two hour drive away from Bad Oeynhausen. "I can live in my own four walls, and I can live with my wife, with my friends, with my children and my mother and everyone. I can live a normal life, and I think that's the best part of the artificial heart and the combination of this portable driver."

Thrun received his CardioWest TAH-t on May 18, 2006. Exactly one year later, he was successfully transplanted with a human heart on May 18, 2007. He was interviewed at his home in the small town of Ennepetal, Germany on Nov. 18, 2006.

The artificial heart works exceptionally well on both continents. In the pivotal clinical study, the TAH-t had a bridge to transplant success rate of 79 percent (New England Journal of Medicine 2004; 351: 859-867). This is the highest success rate of any heart assist device in the world.

The only FDA approved driver available for use with the TAH-t in the U.S. is "Big Blue." This 400 pound driver requires patients to be hospitalized until transplant.

SynCardia Systems, Inc., manufacturer of the CardioWest TAH-t, has taken preliminary steps towards addressing the need for a portable driver in the U.S. and is working with the FDA to move forward in this direction.