| Tucson,
Ariz. – July 25, 2007 – Although
the CardioWest™
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.
###
Media Contact:
SynCardia Systems, Inc.
Director of Communications
Donald Isaacs
520-955-0660
About the CardioWest™ temporary Total Artificial
Heart
The CardioWest™ TAH‑t is a pneumatic, biventricular, implantable bridge-to-transplant
system for full cardiac replacement, taking the place of the failing heart in
patients at imminent risk of death. The device offers full circulatory support,
the shortest blood path and exposure to artificial surfaces, and the highest level
of cardiac output when compared with other artificial heart systems previously
tested. With the CardioWest™ TAH‑t, patients become better candidates for
eventual transplantation and have post-transplant survival rates equal to that
of non-device cardiac recipients.
About SynCardia Systems
Founded in 2001, SynCardia Systems is the developer of biomechanical cardiac replacement
and assist devices. Its CardioWest™ temporary Total Artificial Heart (TAH‑t)
is designed for severely ill patients with end-stage congestive heart failure.
The device serves as an in-hospital bridge-to-transplantation for patients at
imminent risk of death. SynCardia Systems is based in Tucson, Arizona and is on
the Web at http://www.syncardia.com.
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